BLANK PAGE 
MONOGRAPH 

The FTC 

Cigarette Test 

Method for 

Determining 

Tar, Nicotins, . 

and Carbon 

Monoxide Yields 

of US. Cigarettes 

Report of the NCI Expert Committee. 

U.S. DEPARTMENT OF HEALTH 

AND HUMAN SERVICES 

Public Health Service 

National Institutes of Health 

Foreword 

In response to the emerging scientific evidence that cigarette smoking 

posed a significant health risk to the user, in the early 1950’s the major 

cigarette manufacturers began widespread promotion of filtered cigarettes 

to reassure smokers that, regardless of whatever unhealthy constituents 

were in cigarette smoke, filters were a “scientific” breakthrough. 

Advertisements for Viceroy’s “health guard filter” stated, “DENTISTS 

ADVISE-Smoke VICEROYS-The Nicotine and Tars Trapped by The Viceroy 

Filter CAN NEVER STAIN YOUR TEETH!” and “Leading N.Y. Doctor,Tells 

His Patients What to Smoke-Filtered Cigarette Smoke Is Better For Health. 

The Nicotine and Tars Trapped . ..Cannot Reach Mouth, Throat Or Lungs.” 

Chesterfield was “Best for you--low in nicotine, highest in quality,” while 

L&M’s were “Just What the Doctor Ordered.” Lorillard Tobacco Company 

stressed its science-based Kent micronite filter (the original micronite filter 

was made of asbestos) and claimed it removed seven times more tar and 

nicotine than any other cigarette, which “put Kent in a class all by itself 

where health protection is concerned.” Of course, we know today that not 

only were these claims patently false, but the cigarette companies knew ,it. 

In the early 1950’s the Federal Trade Commission (FTC) challenged a 

variety of health claims made for cigarettes in their advertising, including 

claims about tar and nicotine. In 1955 FTC published advertising guidelines 

that, among other things, prohibited claims by cigarette manufacturers 

that a particular brand of cigarettes was low in tar and nicotine or lower 

than other brands, when it had not been established by competent scientific 

proof that the claim was true and the difference was significant. Cigarette 

manufactures, however, continued to advertise tar numbers. In the absence 

of a standardized test methodology, this resulted in what is referred to as a 

“tar derby”-a multitude of inconsistent, noncomparable claims that did not 

give consumers a meaningful opportunity to assess the relative tar delivery 

of competing brands. The tar derby ended in 1960 when discussions with 

FTC culminated in an industry agreement to refrain from tar and nicotine 

advertising. 

In 1966, however, the U.S. Public Health Service (PHS) prepared a 

technical report on “tar” and nicotine that concluded, “The preponderance 

of scientific evidence strongly suggests that the lower the ‘tar’ and nicotine 

content of cigarette smoke, the less harmful would be the effect.” In reaching 

this conclusion, the report noted the clear relationship between dose of 

cigarette smoke received by the smoker and disease risk. Regardless of how 

dose was calculated-by number of cigarettes smoked per day, age of 

initiation, total number of years one smoked, or depth of inhalation, 

mortality rates among smokers increased. When smokers quit smoking, 

their risk was reduced in proportion to the length of time off cigarettes. 

iii 
Smoking and Tobacco ControZ Monograph No. 7 

Subsequent to the PHS statement, FTC reversed its decision banning tar 

and nicotine claims in advertising and established a standardized testing 

protocol for assessing tar and nicotine yields. Today that protocol is widely 

known as the FTC test method. In 1980 the protocol was broadened to 

include measurement of the carbon monoxide yields of cigarettes as well. 

The initial protocol adopted by FTC was largely based on the work of 

U.S. Department of Agriculture chemist C.L. Ogg, as published in the IournaZ 

of the Association of OfFcial Agn’cuZturaZ Chemists in 1964. It appears, however, 

that this protocol was based on one person’s observations about how people 

smoked. 

Much the same protocol had been proposed by American Tobacco 

Company researchers in 1936. Writing in the July issue of Industn’aZ and 

Engineering Chemisby, J.A. Bradford and colleagues noted, “The present 

writer’s arbitrarily selected rate is a 35-cc puff of 2-second duration taken 

once a minute.” 

However, cigarettes consumed at that time were vastly different from 

those manufactured and marketed later. In fact, tar and nicotine levels 

began to decline during the 195O’s,concurrent with the mass marketing of 

filter cigarettes. Market share of filter cigarettes increased from almost zero 

in 1950 (0.6 percent of the market) to 50 percent by decade’s end. Total 

cigarette sales, which had begun to decline after the first public statements 

about the hazards of smoking in the early 195O’s,rebounded to new highs. 

Although filter efficiency may have contributed to some of the reduction 

in tadnicotine yields in the 195O’s,the decline resulted mostly from less 

tobacco being used to make filtered as opposed to unfiltered cigarettes. 

However, during the 1960’s and 1970’s major cigarette design changes 

resulted in significantly lower machine-measured cigarette yields. The 

changes included increased use of ventilated tobacco rods and filters, 

use of more porous cigarette papers, and increased use of expanded and 

reconstituted tobacco. Concurrent with these modifications in cigarette 

design, cigarette manufacturers increasingly made use of additives in 

manufacturing. Today about 600 different compounds are routinely 

added to domestic cigarette brands, yet no routine testing is performed 

to determine whether these compounds pose any additional health risk 

to the smoker when they are burned in a cigarette. 

U.S. market share of cigarettes yielding 15 mg tar or less went from 

3.6 percent in 1970 to 44.8 percent by 1980. The sales-weighted average tar 

and nicotine yields of all U.S. cigarettes are now approximately 12 mg tar and 

0.9 mg nicotine. By comparison, sales-weighted yields in the early 1950’s 

were 35 mg tar and 2.5 mg nicotine. 

As consumption of low-yield cigarettes began to proliferate, the public 

health community became concerned that these products were not what 

they seemed. Increasingly, scientific studies documented that smokers who 

switched to these low-yield products smoked them differently, thus negating 

iv 
Foreword 

the reason many of them changed in the first place-to lower their health 

risk. 

The U.S. Congress also voiced its concern in 1978 when it enacted the 

Health Services and Centers Act. Section 403 of that legislation directed the 

U.S. Department of Health and Human Services (DHHS) to conduct a “study 

or studies of (1) the relative health risks associated with smoking cigarettes 

of varying levels of tar, nicotine, and carbon monoxide; and (2) the health 

risks associated with smoking cigarettes containing any substances commonly 

added to commercially manufactured cigarettes.” The Secretary of the 

Department of Health and Human Services addressed this issue as part of 

the 1981 Surgeon General’s report, The Health Consequences of Smoking: The 

Changing Cigarette. The overall conclusion of that report was clear: “There 

is no safe cigarette and no safe level of consumption.” Although the report 

did note that smoking cigarettes with lower yields of tar and nicotine 

reduces the risk of lung cancer to some extent, the benefits are minimal 

in comparison with giving up cigarettes entire!y. Evidence relating to heart 

disease, other cancers, or chronic obstructive lung disease was not sufficient 

to permit conclusions to be drawn. As to the accuracy of the FTC test 

method, the report stated: “The ‘tar’ and nicotine yields obtained by present 

testing methods do not correspond to the dosages that the individual smokers 

receive: In some cases they may seriously underestimate these dosages.” 

Growing numbers of questions were raised about the accuracy of the 

FTC test protocol to measure tar, nicotine, and carbon monoxide levels 

from low-yield cigarettes-questions raised not just by the public health 

community but also within the tobacco industry. Competitors complained 

to FTC that Brown and Williamson’s (B&W) Barclay brand cigarette did not 

test accurately with the FTC test method. They argued that the brand was 

designed with unique air ventilation channels that caused it to test low on 

the FTC method. The ventilation channels, which remained open when 

Barclays were smoked on the FTC machine, were rendered inoperable 

when a human being smoked the cigarettes. In April 1983 FTC announced 

that its testing method understated values for constituents in Barclay 

cigarettes, and as a result, until new testing methods were developed, FTC 

would no longer report an official rating for Barclay cigarettes. Later, FTC 

took similar steps with respect to other B&W cigarette varieties that used 

a filter design similar to Barclay’s. 

Eventually FTC closed its cigarette testing laboratory, in part because of 

insufficient expertise within the agency to carry out an increasingly complex 

and costly testing program. Since 1987, constituent levels for domestic 

cigarette brands have been determined for the manufacturers by the Tobacco 

Institute Testing Laboratory with oversight by FTC. The Tobacco Institute 

serves as a trade organization as well as the information and lobbying arm 

of the tobacco industry. 

In June 1994 the Chairman of the House Subcommittee on Health and 

the Environment wrote the Director of the National Cancer Institute (NCI), 

asking him to convene a meeting of experts to ‘I. . .review and make 

V 
Smoking and Tobacco Control Monograph No. 7 

recommendations on the accuracy and appropriateness of the Federal Trade 

Commission’s method for determining the relative ‘tar’ and nicotine content 

of cigarettes.” A similar request was received from the FTC Chairman asking 

that NCI convene a consensus conference on the topic and outlining several 

areas it wished to be considered. 

On December 5 and 6, 1994, a meeting of the NCI ad hoc expert 

committee was convened under the aegis of the President’s Cancer Panel to 

examine this issue. The committee consisted of 11individuals from diverse 

scientific backgrounds and experience. The committee had the benefit of 

excellent presentations from 14 experts whose professional careers were not 

only involved in research on smoking, but who have been active contributors 

to this field of scientific inquiry. Two of the individual participants were 

cigarette industry scientists, who participated in all discussions. 

From the outset of the committee’s deliberations, it was clear that the 

intent of the meeting was not to redesign the FTC testing protocol but, rather, 

to examine the protocol and make suggestions for improvement, if warranted. 

To provide a framework for discussion, the committee was asked to consider 

three basic questions: 

1. Does the evidence presented clearly demonstrate that 

changes are needed in the current FK protocol for 

measuring tar, nicotine, and carbon monoxide? If yes, 

what changes are required? 

2. Should constituents other than tar, nicotine, and carbon 

monoxide be added to the protocol? 

3. Does the FI‘C protocol provide information useful to 

smokers in making decisions about their health? 

I. The committee reached the following conclusions with respect to the first 

question. 

A. The smoking of cigarettes with lower machine-measuredyields has a 

small effect in reducing the risk of cancer caused by smoking, no effect 

on the risk of cardiovascular diseases, and an uncertain effect on the 

risk of pulmonary disease. A reduction in machine-measuredtar yield 

from 15 mg tar to 1mg tar does not reduce relative risk from 15 to 1. 

B. The FTC test protocol was based on cursory observations of human 

smoking behavior. Actual human smoking behavior is characterized 

by wide variations in smoking patterns, which result in wide variations 

in tar and nicotine exposure. Smokers who switch to lower tar and 

nicotine cigarettes frequently change their smoking behavior, which 

may negate potential health benefits. 

C. Accordingly, the committee recommends the following changes to 

the FTC protocol: 

vi 
Foreword 

1. This system should also measure and publish information on the 

range of tar, nicotine, and carbon monoxide yields that most 

smokers should expect from each cigarette sold in the United 

States. 

2. This information should be clearly communicated to smokers. 

3. A simple graphic representation should be provided with each pack 

of cigarettes sold in the United States and in all advertisements. 

The representation should not imply a one-to-one relationship 

between measurements and disease risk. 

4. The system must be accompanied by public education to make 

smokers aware that individual exposure depends on how the 

cigarette is smoked and that the benefits of switching to lower 

yield cigarettes are small compared with quitting. 

D. There should be Federal oversight of cigarette testing, but such testing 

should continue to be performed by the tobacco industry and at 

industry expense. 

E. The questions involved in the purpose, methodology, and utility 

of the FTC protocol are complex medical and scientific issues that 

require ongoing involvement of Federal health agencies, including 

the National Institutes of Health, the Food and Drug Administration, 

and the Centers for Disease Control and Prevention. 

F. The system should be reexamined at least every 5 years to evaluate 

whether the protocol is maintaining its utility to the smoker. 

G. When a cigarette manufacturer makes significant changes in cigarette 

design that affect yields, it should notify the appropriate Federal 

agency. 

11. With regard to the second question, the committee recommends that to 

avoid confusing smokers, no smoke constituents other than tar, nicotine, 

and carbon monoxide be measured and published at the present time. 

Smokers should be informed of the presence of other hazardous smoke 

constituents with each package and with all advertisements. These 

constituents should be classified by toxic effects. 

111. In considering the third question, the committee reached the following 

conclusions: 

A. Information from the testing system is useless to smokers unless 

they have ready access to it. The information from the testing system 

should be made available to all smokers, including those who smoke 

generic brands and other brands not widely advertised. 

B. Brand names and brand classifications such as “light” and “ultralight” 

represent health claims and should be regulated and accompanied, in 

fair balance, with an appropriate disclaimer. 

vii 
Smoking and Tobacco Control Monograph No. 7 

C. The available data suggest that smokers misunderstand the FTC test 

data. This underscores the need for an extensive public education 

effort. 

As Chairman of the President’s Cancer Panel under whose aegis this 

meeting was convened, I would like to express here my admiration and deep 

appreciation to the members of the NCI ad hoc committee and its expert 

consultants for a job well done. In transmitting this report to both the 

U.S. Congress and the Federal Trade Commission, it is my sincere hope 

that the recommendations contained herein will receive the serious and 

thoughtful consideration they deserve. 

Harold P. Freeman, M.D. 

Chairman, President’s Cancer Panel 

viii 
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 JohnM. 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 0.Wilson, Ph.D. 

President’s Cancer Panel National Cancer Institute 

Bethesda, MD 

ix 
Panelists 

Srnokinn and Tobacco Control Mononraph No. 7 

Fred Bock, Ph.D. 

Miami, FL 

Dorothy K. Hatsukami, Ph.D. 

Associate Professor of Psychiatry 

University of Minnesota 

Minneapolis, MN 

Sandra Headen, Ph.D. 

Social/Community Psychologist 

University of North Carolina School of 

Public Health 

Chapel Hill, NC 

Dietrich Hoffmann, Ph.D. 

Associate Director and Chief 

Division of Environmental Carcinogenesis 

American Health Foundation 

Valhalla, NY 

John R. Hughes, M.D. 

Professor 

Departments of Psychiatry, Psychology, 

and Family Practice 

University of Vermont 

Burlington, VT 

Diana Petitti, M.D., M.P.H. 

Director 

Division of Research and Evaluation 

Kaiser Permanente 

Pasadena, CA 

William S. Rickert, Ph.D. 

President 

Labstat, Inc. 

Kitchener, Ontario 

CANADA 

Saul Shiffman, Ph.D. 

Professor 

Department of Psychology 

University of Pittsburgh 

Pittsburgh, PA 

Maxine L. Stitzer, Ph.D. 

Professor 

Department of Psychiatry and Behavioral 

Sciences 

Johns Hopkins University School of Medicine 

Francis Scott Key Medical Center 

Baltimore, MD 

X 
Acknowledgments 

Invited Speakers 

Ray Woosley, M.D., Ph.D. 

Chair 

Department of Clinical Pharmacology 

Georgetown University 

Washington, DC 

Neal L. Benowitz, M.D. 

Professor of Medicine and Chief 

Division of Clinical Pharmacology and 

Experimental Therapeutics 

University of California, San Francisco 

San Francisco, CA 

Joel B. Cohen, Ph.D. 

Distinguished Service Professor and Director 

Center for Consumer Research 

University of Florida 

Gainesville, FL 

Gary A. Giovino, Ph.D., M.S. 

Chief 

Epidemiology Branch 

Centers for Disease Control and Prevention 

Atlanta, GA 

Michael R. Guerin, Ph.D. 

Section Head, Organic Chemistry 

Oak Ridge National Laboratory 

Oak Ridge, TN 

Jeffrey E. Harris, M.D., Ph.D 

Massachusetts General Hospital 

Associate Professor 

Department of Economics 

Massachusetts Institute of Technology 

Cambridge, MA 

Jack E. Henningfield, Ph.D. 

Chief 

Clinical Pharmacology Branch 

Addiction Research Center 

National Institute on Drug Abuse 

Baltimore, MD 

Dietrich Hoffmann, Ph.D. 

Associate Director and Chief 

Division of Environmental Carcinogenesis 

American Health Foundation 

Valhalla, NY 

xi 
Smoking and Tobacco Control Monograph No. 7 

Tobacco Industry 

Representatives 

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 

J. Donald deBethizy, Ph.D. 

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 

Federal Trade Commission: 

C. Lee Peeler, Esq. 

Federal Trade Commission 

A Historical Overview Washington, DC 

xii 
Acknowledgments 

Chapter 2. Review of the Federal Trade 

Commission Method for 

Determining Cigarette Tar 

and Nicotine Yield 

Chapter 3. Changes inCigarette 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 
Smoking and Tobacco Control Monograph No. 7 

Chapter 5. Cigarette Smoke Components 

and Disease: Cigarette 

Smoke IsMore Than a 

Triad of Tar, Nicotine, 

and Carbon Monoxide 

Jeffrey E. Harris, M.D., Ph.D. 

Massachusetts General Hospital 

Massachusetts Institute of Technology 

Cambridge, MA 

Chapter 6. The Changing Cigarette and 

Disease Risk: Current Status 

of the Evidence 

Jonathan M. Samet, M.D., M.S. 

Johns Hopkins University 

Baltimore, MD 

School of Hygiene and Public Health 

Chapter 7. Biomarkers ofCigarette 

Smoking 

Neal L. Benowitz, M.D. 

University of California, San Francisco 

San Francisco, CA 

Chapter 8. Pharmacology and Markers: 

Nicotine Pharmacology and 

Addictive Effects 

Jack E. Henningfield, Ph.D. 

Addiction Research Center 

National Institute on Drug Abuse 

Baltimore, MD 

Leslie M. Schuh, Ph.D. 

Wayne State University 

Detroit, MI 

Chapter 9. Consumer/Smoker 

Perceptions of Federal Trade 

Commission Tar Ratings 

Joel B. Cohen, Ph.D. 

University of Florida 

Gainesville, FL 

Chapter 10. Sensitivity of the Federal 

Trade Commission Test 

Method to Analytical 

Parameters 

Michael R. Guerin, Ph.D. 

Oak Ridge National Laboratory 

Oak Ridge, TN 

Chapter 11. Human Smoking Patterns James P. Zacny, Ph.D. 

University of Chicago 

Chicago, IL 

Maxine L. Stitzer, Ph.D. 

Johns Hopkins University School 

of Medicine 

Francis Scott Key Medical Center 

Baltimore, MD 

Chapter 12. Compensation for Nicotine 

by Smokers of Lower Yield 

Cigarettes 

Lynn T. Kozlowski, Ph.D. 

Pennsylvania State University 

University Park, PA 

Janine L. Pillitteri 

Pennsylvania State University 

University Park, PA 

xiv 
Acknowledgments 

Chapter 13. Cigarette Design David E. Townsend, Ph.D. 

Technologies Reduce Smoke R.J. Reynolds Tobacco Company 

Yield and Expand Consumer Bowman Gray Technical Center 

Choices: The Role and Utility Winston-Salem, NC 

of the F K Test Method 

SECTION IV. Overview of 1980to 1994 Michael D. Mueller, M.S.P.H. 

Research Related to the R.O.W. Sciences, Inc. 

Standard Federal Trade Rockville, MD 

Commission Test Method 

for Cigarettes 

Finally, the Coordinator and STCP staff members would like to 

acknowledge the significant contributions ofthe following staff 

members of R.O.W. Sciences, Inc., Rockville, MD,and MasiMax 

Resources, Inc., Rockville, MD,who provided technical and 

editorial assistance inthe preparation ofthis monograph. In 

particular, we would like to acknowledge the contribution of 

Richard H. Amacher?M.S., who served as Project Manager from 

September 1989through August 1995 for the contract under which 

this publication was produced. We would also like to thank 

MudZyn M.Massey, M.P.H., MasiMax Resources, andJacqueline M. 

TressZw, R.O.W. Sciences, who currently serve as Project Manager 

and Subcontract Manager, respectively, for the contract under 

which this publication was produced, for their valuable 

contribution during the final phases of the mongraph’s 

development. Special recognition is also due to James R. Libbey, 

M.P.I.A., who served as Managing Editor for this publication, and 

Traci Chenler, who served as Senior Conference Specialist for the 

NCI ad hoc committee meeting that resulted in this monograph. 

R.O.W. Sciences, Inc. 

Douglas Bishop, Art Director 

Catherine W. Chapman, Executive Assistant 

Rebecca A. Charton, Senior Librarian 

Ruth E. Clark, Word Processing Specialist 

Daria T. Donaldson, Proofreader 

Catherine Hageman, Word Processing Supervisor 

Stephen P. Luckabaugh, Information Specialist 

Frances Nebesky, Senior Copyeditor 

Sheila Proudman, Technical Writer/Resource Coordinator 

Esther M. Roberts, Administrative Assistant 

Donna Selig, Copyeditor/Proofreader 

xv 
Smoking and Tobacco Control Monograph No. 7 

Keith W. Stanger, Graphics Services Coordinator 

Donna Cay Tharpe, Quality Control Proofreader 

Sonia Van Putten, Word Processing Specialist 

MasiMax Resources,Inc. 

Rebecca H. Razavi, Copyeditor/Proofreader 

Aida M. Teymouri, Administrative Secretary 

ABOUT THE MONOGRAPH 

This volume is the seventh in the series of Smo ing an( Tobacco Contrc 

monographs published by the National Cancer Institute since 1991. The 

monographs were specifically established by NCI to provide an authoritative 

source of information about issues important to those individuals and 

institutions involved in smoking and tobacco use control. 

This report was compiled in response to a request to the National Cancer 

Institute by the then Chairman of the Subcommittee on Health and the 

Environment, U.S. House of Representatives, asking that a scientific panel of 

experts be convened to review and make recommendations on the accuracy 

and appropriateness of the Federal Trade Commission’s test method for 

assessing constituent yields for cigarettes on the U.S. market. The NCI 

received a similar but more detailed letter from the Chairman of the Federal 

Trade Commission in which the Commission outlined several areas for the 

NCI ad hoc committee to consider (see page xix). 

The Coordinator of NCI’s Smoking and Tobacco Control Program, who 

was given overall responsibility for the project, established a small informal 

advisory group consisting of individuals from the FIC and various PHS 

agencies to help organize the conference, suggest committee members, and 

plan the agenda. 

The NCI Ad Hoc Committee of the President’s Cancer Panel on the 

FK Test Method for Determining Tar, Nicotine, and Carbon Monoxide 

Levels in Cigarettes was convened December 5-6, 1994, in Bethesda, MD. 

Harold P. Freeman, M.D., Chairman of the President’s Cancer Panel, also 

chaired these proceedings. 

However, prior to the December conference the 11members of the NCI 

ad hoc committee (these individuals are identified in the “Acknowledgments” 

to the monograph) were provided several resource materials in support of 

their deliberations. These resources included copies of the 1981 Surgeon 

General’s report The Health Consequences of Smoking: The Changing Cigarette. 

A Report ofthe Surgeon General, a detailed bibliography of the relevant 

worldwide scientific literature, and a copy of an NCI-commissioned White 

Paper titled “Overview of 1980 to 1994 Research Related to the Standard 

Federal Trade Commission Test Method for Cigarettes.” The White Paper, 

which is published as Section IV of this monograph, represents a noncritical 
Acknowledgments 

summary of those research findings published since the 1981 Surgeon 

General’s report. Full copies of all articles were made available on demand 

to members of the NCI ad hoc committee by NCI’s information science 

contractor, R.O.W. Sciences, Inc., of Rockville, MD. 

The December 5-6, 1994, conference was organized similar to a consensus 

conference. Prior to the formal opening of the conference, the committee 

was asked to consider the three questions laid out on page vi of the 

“Foreword.” 

On the first day, subject matter experts were invited to make formal, 

structured presentations before the NCI ad hoc committee. (See 

“Acknowledgments” for list of speakers.) The 13 individual chapters 

published in Section I of this monograph are based on these presentations. 

Each presentation was approximately 30 minutes in length, followed by a 

question-and-answer session. Both members of the NCI ad hoc committee 

and invited speakers fully participated in these discussions. During the 

second day of deliberations, committee members and invited speakers 

participated in a more open-ended discussion, with the goal of reaching 

consensus on the three questions. 

Open discussions ended midday December 6. Members of the NCI ad 

hoc committee then met to finalize their recommendations and findings; 

these were presented to the public during a press conference midafternoon 

December 6. The FTC Cigarette Test Method for Determining Tar, Nicotine, and 

Carbon Monoxide Yields of U.S. Cigarettes: Report of the NCI Ad Hoc Committee 

is the culmination of that effort. 

Individuals wishing to receive a copy of the audiotapes of the December 

meeting may order these directly from Caset Associates at (703) 352-0091. 

The cost per set is $75. Those individuals interested in receiving 

a copy of the written transcript should contact Mr. Donald R. Shopland, 

National Cancer Institute, Executive Plaza North, Room 241, 6130 Executive 

Boulevard, Bethesda, MD 20892-7337. 

xvii 
BLANK PAGE 
Acknowledgments 

OMS WORW THIRD CONGRESS 

U.S. HOUSE OF REPRESENTATIVES 

COMMllTEE ON ENERGY AND COMMERCE 

m 

SUBCOMMllTEE ON HEALTH AND THE ENVIRONMENT 

24 16 RAYBURN HOUSE OFFICE BUILDING 

WASHINGTON, DC 206 16-6 1 18 

UILN NELUY 61 PHONE I2021126-4962 

June 7,1994 

Dr. Samuel Broder 

Director 

National Cancer Institute 

National Institutes of Health 

Building 31 

Room 11A48 

9OOO Rockville Pike 

Bethesda, Maryland 20892 

Dear Dr. Broder: 

I am writing to request that the National Cancer Institute sponsor a scientific 

conference which would review and make recommendations on the accuracy and 

appropriateness of the Federal Trade Commission's method for determining the relative 

"tat' and nicotine content of cigarettes. As you know, there is growing concern over the 

current testing method because many public health and addiction experts believe it may 

mislead smokers about the relative safety of a low tar, low nicotine product. 

It has been suggested that a major reason for reliance upon the FIT test 

procedure is to allow consumers the option of reducing their risk of disease by smoking a 

brand deemed low in "tar" and nicotine. Consumer preference for low tar and nicotine 

rated cigarettes accelerated during the 1970's when NCI supported research strongly 

suggested that such cigarettes offered the consumer a reduced risk of lung cancer. The 

shift in consumer demand to these newer low yield cigarettes was quite rapid. In 1972 

less than 2 percent of all cigarettes sold in the U.S. had a tar yield of less than 15 mg. 

However, the major cigarette manufacturers were quick to use the FTC tar and nicotine 

numbers in their advertising and by the end of the decade 40 percent of all cigarettes 

sold were under 15 mg. During the 1980's considerable doubt was expressed by many 

public health officials as to whether the tar and nicotine yields of cigarettes based on a 

protocol developed in the 1950's accurately reflect actual exposure and health risk levels 

when smoking today's cigarettes. Today approximately 60 percent of all brands are 

considered low-tar. 

xix 
Smoking and Tobacco Control Monograph No. 7 

The NCI can provide an invaluable public service in sponsoring a scientific forum 

to address these issues and formulate alternative recommendations. It would be 

particularly helpful if a conference on this matter, perhaps in collaboration with the 

National Institute on Drug Abuse and the Federal Trade Commission,could be convened 

by October 1994. 

Your consideration of this request is greatly appreciated. Please do not hesitate 

to contact me or Ripley Forbes of the Subcommittee staff if we can answer any questions 

or provide assistance in developing a conference agenda. I look forward to hearing from 

You. 

With every good wish, I am 

Sincerely, 

HENRY d WAXMAN 

Chairman, Subcommittee on 

Health and the Environment 

. 
Contents 

Page 

Foreword ................................................. iii 

Acknowledgments.......................................... ix 

SECTION I. Invited Papers 

Chapter 1. Cigarette Testing and the Federal Trade Commission: 

A Historical Overview. ................................... 1 

Question-and-Answer Session. ................................ 8 

References ................................................ 8 

Chapter 2. Review of the Federal Trade Commission Method for 

Determining Cigarette Tar and Nicotine Yield ............. 9 

Question-and-Answer Session. ................................ 12 

References ................................................ 14 

Chapter 3. Changes in Cigarette Design and Composition 

Over Time and How They Influence the Yields 

of Smoke Constituents ................................... 15 

Introduction .............................................. 15 

Background ............................................... 15 

Changes in Cigarette Design and Composition ................... 18 

Summary .................................................. 31 

Question-and-Answer Session. ................................ 33 

References ................................................ 35 

Acknowledgments .......................................... 37 

Chapter 4. Attitudes, Knowledge, and Beliefs About Low-Yield 

Cigarettes Among Adolescents and Adults ................. 39 

Introduction .............................................. 39 

Monitoring National Data ................................... 42 

SuIvey Findings ............................................ 43 

Health Beliefs and Switching ................................. 47 

Quitting Smoking .......................................... 49 

Discussion ................................................ 51 
Chapter 5. 

Chapter 6. The ChangingCigarette and Disease Risk 

CurrentStatusoftheEvidence ............................ 77 

Smoking and Tobacco Control Monograph N o.7 

Question-and-Answer Session ................................. 53 

References ................................................ 56 

Cigarette Smoke Components and Disease: 

Cigarette Smoke Is More Than a Triad of Tar. 

Nicotine. and Carbon Monoxide ........................... 59 

Introduction .............................................. 59 

Mainstream Vs .Sidestream Cigarette Smoke ..................... 59 

Major Health Effects of Cigarette Smoke ........................ 60 

Cancer ................................................... 61 

Noncancerous Lung Diseases ................................. 62 

Atherosclerotic Cardiovascular Diseases ......................... 63 

Cigarette Smoking and Human Reproduction .................... 65 

Absolute Risk Vs.Relative Risk ................................ 66 

Tar. Nicotine. Carbon Monoxide. and Other 

Smoke Constituents ........................................ 66 

Smoke Constituents. Cigarette-Related Disease. 

and Modified Labeling of Cigarettes ........................... 67 

Question-and-Answer Session ................................. 70 

References ................................................ 72 

Acknowledgment .......................................... 75 

Introduction ........................................... 77 

Epidemiologic Evidence on the Changing Cigarette 

and Disease Risks ........................................ 79 

Conclusions............................................... 86 

Question-and-Answer Session ............................... 87 

References ................................................ 91 

Chapter 7. Biomarkers of Cigarette Smoking ......................... 93 

Introduction .............................................. 93 

Use of Various Biomarkers ................................... 93 

Nicotine Absorption From Cigarettes ........................... 93 

xxii 
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 

xxiii 
Smoking and Tobacco Control Monograph No. 7 

Chapter 10. Sensitivityof the Federal Trade Commission 

Test Method to Analytical Parameters .................... 

Introduction .............................................. 

Standard Machine Smoking .................................. 

Influence of Smoking Parameters ............................. 

Influence of Human Smoking Practices ........................ 

Conclusions .............................................. 

Question-and-Answer Session ................................ 

References ............................................... 

Acknowledgments ......................................... 

Chapter 11. HumanSmoking Patterns ............................... 

Introduction .............................................. 

How Do Humans Smoke? ................................... 

Which Human Smoking Behaviors Determine 

SmokeExposure? .......................................... 

Are Human Smoking Patterns Dynamic or Static? ................ 

Does the FTC Method Accurately Reflect Human 

SmokingPatterns? ......................................... 

Summary ................................................ 

Question-and-Answer Session ................................ 

References ............................................... 

Chapter 12. Compensationfor Nicotine by Smokers of 

Lower Yield Cigarettes ................................... 

Background .............................................. 

Cigarette Brand Switching in Experimental Research .............. 

Research ................................................. 

One Repeated-Measures Study of Self-selected 

Brandswitching ........................................... 

Smokers Can Get High Yields From the Lowest of the 

Low-Yield Cigarettes: More on the Issue of Vent Blocking ......... 

Graphic Information on Tar and Nicotine Yields: 

The Color-Matching Technique .............................. 

135 

135 

135 

137 

141 

149 

149 

149 

150 

151 

151 

151 

152 

153 

154 

156 

157 

159 

161 

161 

161 

162 

165 

165 

166 

xxiv 
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 ETC 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 I1. Transcript of Second-Day Discussion ...................... 193 

SECTION I11. Recommendations and Findings .......................... 239 

SECTION N. Overview of 1980 to 1994 Research Related 

to the StandardFederal Trade Commission Test 

Method for Cigarettes ................................... 249 

Introduction .............................................. 249 

Parameters of the FTC Test Method and Current 

SmokingPatterns .......................................... 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 FTC Test 

Method and Amount of Nicotine Absorbed by Smokers ........... 257 

Yield by the FTC Test Method and Absorption of Nicotine 

inswitchers .............................................. 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 
BLANK PAGE 
Chapter 1 

Cigarette Testing and the Federal Trade 

Commission: A Historical Overview’ 

C. Lee Peeler 

Cigarette manufacturers began advertising their products’ tar and 

nicotine content before there was a standardized procedure for testing 

cigarette output. In 1955, after a series of cases challenging a variety of 

claims made for cigarettes (including tar and nicotine claims),’ the Federal 

Trade Commission (Commission or FTC) published cigarette advertising 

guides. Among other things, the guides prohibited claims that a particular 

brand of cigarettes was low in tar and nicotine or lower than other brands 

“when it has not been established by competent scientific proof. . . that the 

claim is true, and if true, that such difference or differences are significant” 

(Federal Trade Commission, 1988a). 

However, cigarette manufacturers continued to advertise tar numbers. 

In the absence of a standardized testing methodology, their claims resulted 

in what is often referred to as the “tar derby”-a multitude of inconsistent, 

noncomparable claims that did not give consumers a meaningful opportunity 

to assess the relative tar delivery of competing brands. The tar derby ended 

in 1960, when discussions with the Commission culminated in an agreement 

by the industry to refrain from tar and nicotine advertising (Federal Trade 

Commission, 1988b). 

In 1964 the first Surgeon General’s report on the health risks of smoking 

concluded that cigarette smoking was a cause of lung cancer in men (U.S. 

Department of Health and Human Services, 1964). In 1966 the Public 

Health Service stated that “The preponderance of scientific evidence strongly 

suggests that the lower the tar and nicotine content of cigarette smoke, the 

less harmful would be the effect” (U.S. Department of Health and Human 

Services, 1981, p. v). 

It was in this environment that the Commission initiated two major 

steps in 1966 to encourage cigarette manufacturers to provide consumers 

with comparative information about their products’ tar and nicotine yields. 

’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. 

2See, e.g., R.1. Reynolds Tobacco Co. v. ETC,192 F.2d 535 7th Cir. (1951) (claims that Camel does not impair the 

physical condition of athletes and aids digestion); Arnerkan Tobacco Co., 47 F.T.C. 1393 (1951) (Lucky Strike 

cigarettes advertised as less irritating to the throat than competing brands and containing less tar than four 

other leading brands); P. Lorillard Co., 46 F.T.C. 735 (1950) (Old Gold cigarettes advertised as lowest of seven 

leading brands in nicotine and throat irritating tars, and Beech-Nut cigarettes as providing “definite defense 

against throat irritation”). See also, eg., Leighton Tobacco Co., 46 F.T.C. 1230 (1950) (Phantom cigarettes 

represented as causing no irritation of any kind). 

1 
Smoking and Tobacco Control Monograph No. 7 

First, it ended the ban on tar and nicotine advertising by announcing that 

factual statements of the tar and nicotine content of mainstream cigarette 

smoke could be made if they were supported by tests conducted in accordance 

with the so-called “Cambridge Filter method” and if they were not 

accompanied by claims about reduced health hazards (Federal Trade 

Commission, 1988a). Second, it authorized establishment of a laboratory to 

analyze cigarette smoke and invited public comment on what modifications, 

if any, should be made to the Cambridge Filter method for purposes of the 

laboratory’s procedures and how the test results should be expressed (Federal 

Register, 1966). The modified Cambridge Filter method ultimately adopted 

by the Commission is often referred to as the “FTC method.” 

By mid-1967 the laboratory was ready to begin testing cigarettes 

(Federal Register, 1967).3 The Commission agreed, pursuant to Senator 

Warren Magnuson’s reque~t,~ to report the test results to Congress 

periodically, a process that continues today. 

From the outset, the testing was intended to obtain uniform, 

standardized data about the tar and nicotine yield of mainstream cigarette 

smoke, not to replicate actual human smoking. The Commission recognized 

that individual smoking behavior was just that-too individual to gauge 

what a hypothetical “average” smoker would get from any particular cigarette: 

“No two human smokers smoke in the same way. No individual smoker 

always smokes in the same fashion” (Federal Trade Commission, 1967). The 

purpose of the testing was “not to determine the amount of ‘tar’ and nicotine 

inhaled by any human smoker, but rather to determine the amount of tar 

and nicotine generated when a cigarette is smoked by machine in accordance 

with the prescribed method” (Federal Trade Commission, 1967). Indeed, the 

Cambridge Filter method did not attempt to duplicate an “average” smoker 

but was “an amalgam of many choices” (Federal Trade Commission, 1967). 

Because no test could accurately duplicate human smoking, the Commission 

believed that the most important thing was to make certain the results 

presented to the public were based on a reasonable, standardized method 

and could be presented to consumers in an understandable manner. 

The Commission next attempted to increase consumer awareness of the 

ratings produced by its laboratory. In 1970 it proposed a trade regulation rule 

that would have required disclosure of tar and nicotine ratings in all cigarette 

For the first dozen years of its existence, the laboratory tested only for tar and nicotine. In 1980the protocol 

was modified to add testing for carbon monoxide. 

Expressing the opinion held at that time by many people in the Federal Government, Senator Magnuson 

stated that “By encouraging smokers to switch to low tar/nicotine cigarettes, we can contribute meaningfully 

to the physical health of our nation. Publication of the Commission’s testing results is one important facet 

The Commission expressed its views concerning dissemination of tar and nicotine figures in an October 1967 letter to the National Association of Broadcasters: “The Commission favors giving smokers 

as much information about the risks involved in smoking as is possible and to that end favors mandatory 

disclosure of tar and nicotine content, as measured by a standard test.” 

2 
ChaDter 1 

advertising (Federal Register, 1970). The rulemaking was suspended 

indefinitely a short time later, when five of the major cigarette manufacturers 

and three small companies agreed voluntarily among themselves to include 

the ratings produced by the Commission’s protocol in their advertisements. 

That agreement, modified to reflect the discontinuance of the Commission’s 

laboratory, remains in effect today.’ 

There are a number of ways to lower a cigarette’s tar and nicotine rating, 

including adding filters that literally trap some of the constituents of the 

tobacco smoke before they reach the machine, wrapping the tobacco plug in 

paper that burns relatively quickly, and placing ventilation holes around the 

circumference of the filter so that when a smoker or smoking machine puffs 

on the cigarette, air is drawn into the filter and the resulting diluted mixture 

of air and smoke yields lower tar and nicotine ratings than an undiluted puff 

of smoke would yield. The last technique is often referred to as “aeration.” 

These types of changes in cigarette technology have focused the 

Commission’s attention on its protocol on two separate occasions since 1970. 

In both cases, the Commission solicited public comments on certain aspects 

of the FTC method. However, in neither instance did the information 

received by the Commission form a sufficient basis for changing the protocol, 

even though the limitations on the predictiveness of the FIT method caused 

by compensatory smoking were clearly recognized by the mid-1980’s. 

(“Compensatory behavior” is the tendency of consumers to offset the benefits 

of a positive change in their behavior by making a second, negative change. 

For example, a smoker who switches to a brand with lower tar and nicotine 

ratings might smoke more cigarettes each day or smoke each one more 

intensively, that is, inhale more deeply and/or take more puffs per cigarette.) 

Following is a review of the two events referred to above. 

Aeration first became an issue for the Commission in 1977, when 

Lorillard, Inc., suggested that the depth to which cigarettes were inserted in 

the Commission’s smoking machine be decreased when the standard depth 

would block some of a cigarette’s ventilation holes, thereby impairing its 

filtration system and resulting in higher ratings than if the holes were open. 

The Commission solicited public comments on this question and also on 

whether the insertion depth should be decreased beyond the point where 

consumers cover the cigarette with their fingers or lips (Federal Register, 1977). 

Of the seven cigarette companies that commented, only Lorillard 

supported varying the standard insertion depth. However, none of the 

responders addressed the question of whether the new insertion depth 

would be more consistent with actual smoking practices. After reviewing 

The American Tobacco Company did not sign the voluntary agreement, but similar disclosures have been 

contained in its advertisements, pursuant to a 1971 consent agreement with the Commission. [Inre American 

Brands, Inc., 79 F.T.C. 255 (1971).] 

3 
Smoking and Tobacco Control Monograph No. 7 

the comments, the Commission noted that the development of cigarettes 

with ventilation holes near the tip had complicated the comparability of its 

tar and nicotine ratingsI6 but “that a change in the insertion depth would 

cause a lack of continuity with previous test results” (Federal Register, 1978, 

pp. 11856, 11857). The Commission decided not to modify the protocol “in 

the absence of information indicating that a new insertion depth would be 

more consistent with the manner in which smokers insert cigarettes in actual 

use” (Federal Register, 1978, p. 11857). 

Another controversy concerning the test method arose in the early 1980’s 

and involved the Brown & Williamson Tobacco Corporation’s (B&W) Barclay 

cigarette, which was designed with a channel ventilation system rather than 

air holes.’ Competitors claimed that Barclay, which had received an official 

FTC rating of 1 mg tar in 1981, did not test accurately on the FTC smoking 

machine because the channels remained open during testing but were 

rendered inoperable in practice. After careful consideration, the Commission 

determined that its present test method did not accurately measure Barclay’s 

tar, nicotine, and carbon monoxide. It revoked the 1-mg rating, estimating 

that Barclay should be rated between 3 and 7 mg of tar (based on testing by 

independent consultants) and invited comments on a number of issues 

relating to possible modification of its testing method, including using new 

cigarette holders on the smoking machine that would simulate the reduction 

in ventilation that occurred when people smoked Barclay (Federal Register, 

1983). The Commission asked which modifications would yield the most 

appropriate results for all cigarettes and whether modification of the cigarette 

testing method would result in unintended consequences and affect possible 

innovation in cigarettes design (FederaZ Register, 1983). 

The Commission also took this opportunity to reiterate that its ratings 

were relative; that the amount of tar, nicotine, and carbon monoxide any 

particular cigarette delivered depended on how it was smoked; and that 

in the case of ventilated filter cigarettes, delivery would be increased if 

ventilation holes were blocked (FederaZ Register, 1983). It then invited 

Quoting its 1967 statement that the purpose of testing was not to determine the amount of constituents 

inhaled by a human smoker but to determine the amount generated when a cigarette was smoked by a 

machine in accordance with a prescribed protocol (see above), the Commission noted that: 

The point of this statement was that the FK’s “tar” and nicotine values represented valid 

standards for making comparisons among different cigarettes. Thus, if the consumer smoked 

each different cigarette the same way, he would inhale “tar” and nicotine in amounts proportional to the relative values of the FlT figures. A person who smoked a 10 mg “tar” cigarette 

would ingest half the “tar” he would by smoking a 20 mg “tar” cigarette providing he smoked 

the same way. The development of cigarettes with ventilation areas within 11mm of the tip 

has complicated this simple relationship. (Federal Register, 1978, p. 11856) 

In conventional aerated cigarettes, air and smoke mixed together as they passed through the filter. Outside air 

drawn into Barclay’s channels, however, went directly into the smoker’s mouth before first mixing with any 

smoke; dilution was supposed to occur in the mouth, not in the filter. Competitors alleged that because the 

exit holes for the channels were close to the smoker’s lips, they were crushed or covered by lips, thus reducing 

dilution. 

4 
Chapter 1 

comments on a wide range of issues concerning compensatory smoking 

behavior: 

Should the Commission further examine the implications for its 

testing program of the issues raised by compensatory smoking 

behavior, including hole blocking, when consumers smoke 

lower “tar” cigarettes? What is the evidence that smokers use 

higher “tar” cigarettes differently than lower “tar” cigarettes? 

What is the evidence regarding the extent of hole blocking 

by smokers of different ventilated filter cigarettes? Are there 

problems regarding compensatory smoking behavior which are 

significant enough to warrant further exploration of changes 

in the method, beyond those necessitated by the Commission’s 

findings concerning Barclay? What lines of inquiry would 

generate the most useful information if such an examination 

is undertaken? For example, should the Commission explore 

a system of categories or “bands” of “tar” content rather than 

specific numerical estimates? Also, should consumers be 

advised that the cigarettes’ actual “tar” delivery depends on 

how it is smoked? (Federal Register, 1983) 

Shortly after the initial comment period closed,’ a Federal district 

court issued an opinion in the Commission’s action against BbW over 

advertisements that continued to describe Barclay as a l-mg tar cigarette, 

despite the Commission’s revocation of Barclay’s l-mg rating [FTC v. 

Brown & Williamson Tobacco Corp., 580 F. Supp. 981 (D.D.C. 1983), urd in 

part, remanded in part, 778 F.2d 35 (D.C. Cir. 1985)l. During that litigation, 

BSTW contended that “recent scientific evidence demonstrates that the 

FTC system is so flawed that it is itself deceptive” [580 F. Supp. at 9841.’ 

The court recognized that compensatory smoking behavior complicated 

the ratings question but rejected BSTW’s contention that the system provided 

no benefit to consumers: 

The FTC system attempts only to determine how much relative 

tar and nicotine a smoker would get in his mouth were he to 

smoke two cigarettes in the same manner. BSTW has utterly 

failed to show that the system does not do this. Nor has it 

shown that a better method for determining the relative health 

Comments responsive to the April 13, 1983, Federal Register notice were originally due by June 30, 1983. 

On June 4, 1984, however, the Commission reopened the comment period because certain information 

that was relevant to the questions addressed in that notice, but had been previously under a court-ordered 

seal, was now publicly available (Federal Register, 1984). 

B&W argued that all cigarettes were subject to compensatory smoking behavior and thus all tar numbers 

were “soft.” The Commission acknowledged that low-yield cigarettes were subject to substantial variations 

in actual smoker intake but contended that Barclay tested differently on the machine from other cigarettes. 

The Commission’s position was that the tar ratings provided a rough comparative scale; that is, a l-mg 

cigarette should be comparable to all other l-mg cigarettes, if all are smoked in an identical manner. 

5 
Smoking and Tobacco Control Monograph No. 7 

hazards of the many different varieties of cigarettes on the 

market is currently feasible [580F. Supp. at 9851. 

The comments ultimately submitted in response to the Commission’s 

questions about compensatory smoking reflected sharply disparate views. 

On the one hand, the American Heart Association (AHA), American Lung 

Association (ALA), and American Cancer Society (ACS) identified problems 

with the existing methodology, expressed concern over the impact of 

compensatory smoking behavior, and suggested extensive research to 

improve the current testing and reporting procedures.” 

On the other hand, Philip Morris, R.J. Reynolds Tobacco Company, 

and American Brands asserted that compensatory smoking behavior was 

not relevant to the testing methodology and that devising a protocol that 

accounted for compensatory smoking would require establishing a profile of 

the average smoker, something the Commission had previously declined to 

do because of the impossibility of accounting for all the relevant variables. 

Lorillard stated that data on compensatory smoking were very limited and 

therefore recommended that the existing system be kept intact. Liggett & 

Myers suggested that perhaps all cigarette testing should be abolished because 

smoking behavior could seriously affect tar and nicotine yields and smokers 

could not be taught to change their behavior. 

In response to the Commission’s question about possible implementation 

of a “banding” system for its tar and nicotine ratings, B&W (which had 

just had Barclay’s rating revoked) argued that the current system caused 

manufacturers to emphasize small differences that might not exist, given 

the realities of compensatory smoking, and that it should be replaced with 

a system that would group products into high-tar, medium-tar, low-tar, and 

ultralow-tar “bands.” Philip Morris and American Brands argued that banding 

would lead to a concentration of brands at the upper limit of each category 

(in contrast to the existing system, which encouraged reductions across the 

board). American Brands also contended that banding would confuse 

consumers, whereas Philip Morris noted that it would substitute the 

Government’s judgment about the significance of differences in tar ratings 

for that of the individual consumer. 

lo The ALA stated that given the reality of compensatory smoking, low-tar cigarettes might not be as safe as 

some consumers were being led to believe and that the Commission’s testing and reporting procedures were 

contributing to questionable advertisements for “safe” cigarettes. The ACS stated that the Commission’s test 

method should be modified to reflect current understanding of compensatory smoking behavior. The AHA 

expressed its view that the Commission’s testing and reporting procedures fostered the belief among 

consumers that low-tar cigarettes were safer than high-tar brands. However, epidemiological evidence 

showing a correlation between the risk of coronary heart disease and the number of cigarettes smoked 

per day, but not a reduced rate of such disease among low-tar smokers, suggested that smokers of those 

cigarettes might be engaging in compensatory smoking. 

The ALA and ACS recommended that research be conducted to determine how actual intake of tar and 

other smoke constituents by smokers related to the ETC’s ratings; following completion of this research, 

the Commission should test each cigarette under a range of conditions replicating actual smoking behavior 

and report those results with a warning that individual yield depends on individual smoking patterns. 

6 
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).” 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 year. 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 
Smoking and Tobacco Control Monograph No. 7 

(which are rated as having 1mg of tar per cigarette) than by smoking a single 

pack of certain other brands of cigarettes (rated as having more than 10 mg 

of tar per cigarette). 

The Commission’s desire to ensure that smokers have accurate and useful 

information about their cigarettes led to its request for the conference, whose 

reports are contained in this monograph. 

QUESTION-AND-ANSWER SESSION 

Mr. Peeler conducted a question-and-answer session simultaneously with 

Mr. Pillsbury; see page 12. 

REFERENCES 

Federal Register. 31(215): 14278, November 4, 1966. Federal Trade Commission. Trade Regulation Reporter. 

Federal Register. 32(147): 11178, August 1,1967. Vol. 3. Chicago: Commerce Clearing House, Inc., 

Federal Register. 35(154): 12671, August 8, 1970. 1988b,p 7853.51 at 11730. 

Federal Register. 42(79): 21155, April 25, 1977. U.S. Department of Health, Education, and Welfare. 

Federal Register. 43(56): 11856 and 11857, March 22, Smoking and Health, Report of the Advisory Committee 

1978. to the Surgeon General of the Public Health Senice. 

Federal Register. 48(72): 15953-15955, April 13, 1983. PHS Publication No. 1103. Rockville, MD: U.S. 

Federal Register. 49(108): 23120-23121, June 4, 1984. Department of Health and Human Services, Public 

Federal Trade Commission. “Statement of Health Service, 1964. 

Considerations.” Press release. August 1, 1967, p. 2. U.S. Department of Health and Human Services. The 

Federal Trade Commission. Report to Congress for 1981 Health Consequences of Smoking: The Changing 

Pursuant to the Federal Cigarette Labeling and Cigarette. A Report of the Surgeon General. DHHS 

Advertking Act. Washington, DC: Federal Trade Publication No. (PHS) 81-50156. Rockville, MD: 

Commission, 1984, p. 30 (Table 11). U.S. Department of Health and.Human Services, 

Federal Trade Commission. Trade Regulation Reporter. Public Health Service, Office on Smoking and 

Vol. 6. Chicago: Commerce Clearing House, Inc., Health, 1981. 

1988a, 39,012.70. 

8 
Chapter 2 

Review of the Federal Trade Commission 

Method for Determining Cigarette Tar and 

Nicotine Yield 

Harold C. Pillsbury, Jr.’ 

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 OF 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. 

A particular 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 

The machines are calibrated to take one puff of 2-second duration and 

35-mL volume every minute. Cigarettes are smoked to a butt length of 

23 mm or the length of the overwrap plus 3 mm, whichever is longer. 

When the cigarette has been smoked down to the prescribed length, it 

burns through a string that has been placed on that mark; this causes a 

microswitch to be flipped, which in turn disconnects that particular port 

of the smoking machine. (Although this seems like a fairly unsophisticated 

way of terminating the test, more sophisticated methods-such as infrared 

detectors and thermal sensors-have been tried and rejected over the years.) 

Five cigarettes of each variety are smoked, one at a time, using the same 

filter h01der.~ (A total of 100 cigarettes of each variety are smoked to get the 

official tar, nicotine, and carbon monoxide ratings.) After the smoke from 

those five cigarettes has been filtered through each filter pad, the holder is 

removed and weighed. The difference between the weight of the holder 

before and after the smoking process divided by the number of cigarettes 

smoked is the total particulate matter collected from the cigarette smoke. 

The filter pad is then extracted with a ~olvent,~ and the moisture content 

is determined by injecting a measured amount of the extract into a gas 

chromatograph and comparing the resulting peak against the standard curve. 

Ratings for the three constituents reported by the Commission are then 

determined as follows: 

Nicotine: As with moisture, a specified amount of the extract from the 

filter pad is injected into a gas chromatograph, and the resulting peak 

is compared against the standard curve.’ 

Carbon monoxide: The gas collected in the plastic bag is passed 

through an infrared detector to determine carbon monoxide levels. 

Tar: Tar level is determined by subtracting water and nicotine levels 

from total particulate matter. 

Tar and carbon monoxide figures are rounded up or down to the nearest 

milligram, while nicotine figures are rounded to the nearest 10th of a 

milligram. Varieties with tar and carbon monoxide results below 0.5 mg 

per cigarette or nicotine results below 0.05. mg are reported as <OS mg or 

<0.05 mg, respectively, because the FK test method is not sensitive enough 

to report these components at lower levels. 

Although the ratings are based on 100 cigarettes, at least 150 (and 

preferably 200) cigarettes of each variety are needed for the test to ensure 

To make certain that the machine is working properly, at least 4 of the 20 ports are reserved on each run for 

“monitor” cigarettes-cigarettes with known yields for tar, nicotine, and carbon monoxide. 

The solution contains extractant and internal standards: 2-propanol containing 1mg anethole per mL as 

an internal standard for nicotine and 20 mg ethanol per mL as an internal standard for water. 

Ultraviolet spectroscopy was used to determine nicotine until 1980, when it was replaced by gas 

chromatography. 

10 
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. 

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-ANSUrERSESSION 

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. 

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 
Chapter 2 

MS. WILKENFELD: I think the answer is that, at least originally, we used to 

publish the table with a standard deviation and that therefore there was a 

significance between each degree of tar yield. We do not have confidence 

in yields below .5, and that is announced in the report. 

DR. PETITTI: About how long does it take to finish puffing one cigarette, and 

what is the difference in the time that it might take to puff a cigarette that is 

a very-high-tar cigarette vs. a cigarette that is very low tar? 

MR. PILLSBURY: The difference in the length of time it takes to smoke a 

cigarette is primarily a factor of how long the cigarette is, how tight the 

tobacco is packed, how hard it is, and how much gas flows through the 

cigarettes. Most of the cigarettes take approximately 10 minutes to smoke. 

We have had longer cigarettes that have gone up to 12 to 13 minutes. 

DR. PETITTI: Could you give me a range of the shortest vs. the longest? 

Is it 5 minutes vs. 15, or is it 9 minutes vs. 12? 

MR. PILLSBURY: Any range I would have to give you right now would be a 

guess, because I haven’t followed the range that closely. But I believe that 

probably the shortest cigarette we have ever had is probably around 6 or 

7 puffs per cigarette, and the longest one ran almost 15 puffs, but that was 

a very long cigarette. 

DR. BENOWITZ: Could you explain the rationale for the parameters that are 

used in the current method? How did you arrive at the present protocol? 

MR. PEELER: Let me ask Mr. Pillsbury to address what Dr. Ogg’s rationale 

was in the documents because he actually had an opportunity to discuss that 

with Dr. Ogg. I think that if you look at the documents that the Commission 

published at the time of the adoption of the testing methodology in 1967, 

the Commission is fairly clear that, whatever Dr. Ogg’s rationales were, it 

did not believe it could replicate average smoking conditions. And so it was 

picking parameters that were essentially fairly arbitrary. 

MR. PILLSBURY: When we first started the lab, I talked to Dr. Ogg to quite 

some extent on this topic. He had actually gone out there with a stopwatch 

in his pocket and ridden the trains, and watched people in meetings and 

so forth, and tried to get some feeling for how they were smoking. He came 

back rather confused, because it seemed as though everybody smoked 

differently: from the fellow who got on the train and looked at his 

newspaper and lit his cigarette and never took another puff on it until it 

burned down to the man who was sitting down arguing with somebody, 

smoking like mad. So, he came up with what he considered a fairly average 

way of smoking, so that you didn’t get a big long firebox on the end of 

the cigarette and you kept it burning. 

As far as the butt length is concerned, they went out and picked up 

cigarettes from ash trays in hotels and restaurants and so forth and did actual 

measurements on those. And the best butt length that they could come up 

with was 23, or the overwrap plus 3. 

13 
Smoking and Tobacco Control Monograph No. 7 

MR. PEELER: Again, by the time the Commission adopted the methodology 

in 1967, the Commission was very clear that it was not trying to establish 

average smoking parameters. 

DR. BOCK: I think that it goes back to the 1938 paper by the American 

Tobacco Company group. I talked with Bradford and Harlan in Richmond 

in 1953, and they, again, had gone to parties and watched what their friends 

were doing. They were the same parameters, I believe, and it was based on 

a group of probably upper-middle-income-level Richmondites. 

DR. SHIFFMAN: You mentioned that the original FTC action on this was 

under the FTC’s general authority to prevent deceptive advertising. Now, 

at the moment, you are also reporting the results of these tests to Congress. 

Has there been any evolution in the FTC’s authority in this area, or is it 

still under this broad mandate? 

MR. PEELER: No. The FTC’s involvement in this issue continues to be under 

its authority to regulate deceptive or unsubstantiated claims in advertising. 

And, in the case of tar and nicotine testing in particular, there are two 

variations: (1) We do have a voluntary agreement from the industry to 

include this information in their advertising, and (2) we have had this 

longstanding practice of sending the reports of this testing to Congress, 

which was originally established in response to requests from the Commerce 

Committee. But the only legal authority that we have in this area is our 

authority to require claims in advertising to be truthful and to be 

substantiated. 

DR. COHEN: I want to return to the point of the statistical significance of the 

yields. I think that is a very central question for the record. I would just like 

to point out that there are three different sources of variance here that ought 

to be considered: (1) variance due to product characteristics, such as product 

design features; (2) variance due to individual smoking characteristics; and 

(3)variance due to testing methodology. 

Each of those sources of variance can be estimated separately, and it 

may be very important later on, as the panel does its work, to consider the 

implications of variance in each of those three separately. 

REFERENCES 

-Bradford,J.A., Harlan, W.R., Hanmer, H.R. Nature of Ogg, C.L. Determination of particulate matter and 

cigarette smoke. Technique of experimental alkaloids (as nicotine) in cigarette smoke. Iournal of 

smoking. Industrial and Engineering Chemistry 28(7): the Associationof OfFcial Agticdtural Chemists 47: 

836-839, 1936. 356,1964. 

14 
Chavter 3 

Changes in Cigarette Design and Composition 

Over Time and How They Influence the 

Yields of Smoke Constituents 

Dietrich Hoffmann, Mirjana V. Djordjevic, and Klaus D. Brunnemann 

INTRODUCTION Since the first epidemiological reports on the association of 

cigarette smoking with lung cancer, the composition of tobacco blends 

and the makeup of commercial cigarettes in the United States as well as in 

Western Europe have undergone major changes. Measured on the basis of 

standardized machine smoking conditions, the sales-weighted average tar 

and nicotine deliveries in U.S. cigarette smoke have decreased from 38 mg 

and 2.7 mg, respectively, in 1954 to 12 mg and 0.95 mg, respectively, in 

1993. The lower emissions have been primarily accomplished by using 

efficient filter tips and highly porous cigarette paper and by changing the 

composition of the tobacco blend. The latter includes the incorporation 

of reconstituted and expanded tobaccos into the blend. Concurrent with 

the reduction of tar and nicotine in the smokestream, there also occurred 

a reduction of carbon monoxide, phenols, and carcinogenic polynuclear 

aromatic hydrocarbons (PAHs). These reductions were partially tied to an 

increase in the nitrate content of the tobacco blend used for U.S. cigarettes. 

The addition of nitrate was initially targeted at decreasing the smoke yields 

of PAHs; however, that this also would cause a gradual increase of the 

carcinogenic, tobacco-specific N-nitrosamines (TSNAs) was not recognized 

until there was awareness of those compounds as smoke constituents in 

the 1970's. 

These observations were based on measurements of yields from 

cigarettes that were smoked under standardized laboratory conditions, 

initially established in 1936, and adopted by the U.S. Federal Trade 

Commission (FTC) in 1969. These conditions do not reflect the smoking 

patterns of the smokers of filter cigarettes, who currently account for the 

consumption of 97 percent of all cigarettes produced in the United States. 

The current filter cigarette smoker tends to smoke more intensely and to 

inhale more deeply. Thus, the actual exposure to toxic and tumorigenic 

agents in the inhaled smoke of filter cigarettes is not necessarily in line 

with the machine smoking data. 

BACKGROUND In 1950 epidemiological studies reported that lung cancer was 

particularly prevalent among cigarette smokers (Wynder and Graham, 1950; 

Doll and Hill, 1950). These observations in the United States and the United 

Kingdom were confirmed by the Royal College of Physicians (1962) and by 

the U.S. Surgeon General in 1964 (U.S. Department of Health, Education, and 

Welfare, 1964). These reports and the emerging knowledge of the presence 

15 
Smoking and Tobacco Control Monograph No. 7 

of carcinogens and tumor promoters in cigarette smoke led to a gradual 

change in the design and composition of commercial cigarettes in North 

America, Western Europe, and other developed countries (Hoffmann and 

Hoffmann, 1994a; Jarvis and Russell, 1985). The modifications were intended 

to reduce both the toxicity and the carcinogenic potential of the cigarette 

smoke. Although research on the changing cigarette was pursued in several 

countries, this chapter deals primarily with the developments relating to 

U.S. cigarettes between 1954 and 1993. 

At the basis of all analytical assessments of smoke composition lies the 

standardization of machine smoking methods, first suggested for empirical 

cigarette smoking in Europe (Pfyl, 1933; Pyriki, 1934). In the United States, 

Bradford and colleagues (1936) developed a procedure for cigarette smoking 

on the basis of “arbitrarily selected” parameters of a 35-mL puff volume, 

a 2-second puff duration, and one puff per minute. The only goal of this 

method was to offer a means for comparing the smoke yields of various 

types of cigarettes; there was no intent to simulate human smoking patterns. 

The influences on smoke yields and composition that are exerted by the 

overall physical characteristics of a cigarette-including its length and the 

butt length to which it is smoked, its circumference, whether it is filtered 

or nonfiltered, and the effects of the puff volume, puff frequency, and puff 

duration; the type and cut of tobacco used as a filler; the properties of the 

wrapper; and the mode of precipitation of the condensate-were described 

in many research papers during the 1960’s (Wynder and Hoffmann, 1967). 

For regulatory purposes, Pillsbury and colleagues (1969) adapted in principle 

the method of Bradford and coworkers (1936) and made some refinements 

to establish what became known as the FTC method; the smoking parameters 

were still a 35-mL puff volume, a 2-second puff duration, and a l-puff-perminute frequency. What was new was the definition of the butt length to 

which a cigarette was to be smoked. Butt lengths were set to be 23 mm for 

plain cigarettes and length of the filter plus overwrap with an additional 

3 mm for filter cigarettes. CORESTA, the International Organization for 

Research on Tobacco, developed a comparable method that is widely used 

in most of the developed countries (CORESTA, 1991-1993). 

This chapter describes the analytical data obtained with the FTC method, 

although many studies (Russell, 1980; Herning et al., 1981; Kozlowski et al., 

1982; Fagerstrom, 1982; Haley et al., 1985; Byrd et al., 1994) have shown 

that the standardized machine smoking method does not reflect the smoking 

habits of consumers of filter cigarettes. This is especially so for filter cigarettes 

with low and ultralow smoke yields, because smokers of such cigarettes 

tend to inhale more deeply and draw puffs more frequently to satisfy a 

physiologically conditioned need for nicotine (U.S. Department of Health 

and Human Services, 1988). 

Figure 1presents the sales-weighted average tar and nicotine deliveries 

of all U.S. domestic brands for the years 1954 through 1993 (Hoffmann and 

Hoffmann, 1994a). This figure also shows the major changes in the makeup 

of U.S. cigarettes, such as the introduction of filter tips, porous cigarette 

16 
Chapter 3 

Figure 1 

Sales-weighted average tar and nicotine deliveries, 1954-1993 

401 -3.3

-3.1 

-2.9 

34- RT 

-2.7 

32- -2.5 

30- -2.3 

28- -2.1 h

26- E"

E -1.9 w 

Q) 24- .-C 

W -1.7 c.

.-8 5 22- I- -1.5 

20- -1.3 

18-

-1.1 

16- -0.9 

14- -0.7 

12- -0.5 

10-

I I I I I I 1 I 

0.3 

1950 1955 1960 1965 1970 1975 1980 1990 2000 

All Domestic Brands on US. Market 

Key: RT = reconstituted tobacco; F = filter; ET = expanded tobacco. 

Source: Hoffrnann and Hoffmann, 7994a. 

paper, reconstituted tobacco, filter tip ventilation, and use of expanded 

tobacco. Similar developments occurred in most industrialized countries, 

albeit at a somewhat slower pace and about 5 to 10 years after the 

introduction of these changes in the United States (Hoffrnann and 

Hoffrnann, 1994b;Jarvis and Russell, 1985; U.S. Department of Health 

17 
Smoking and Tobacco Control Monograph No. 7 

and Human Services, 1988). Jarvis and Russell (1985) first observed for 

English cigarettes that the smoke delivery of nicotine was not reduced to 

the same extent as that of the tar. During the past 10to 15 years, the same 

observation was made for U.S. cigarettes. Figure 1does not reflect the 

gradual change in the tobacco blend of U.S. cigarettes with regard to an 

increase of the burley tobacco share from about 35.9 percent in 1950 to 

46.5 percent in 1982; the remainder of the tobacco blend consists primarily 

of bright tobacco with about 5 to 8 percent oriental tobacco and 1percent 

Maryland tobacco (Grise, 1984). 

CHANGES IN Since 1955 the U.S. sales-weighted average smoke yields have 

CIGARETTE declined from 38 mg tar and 2.7 mg nicotine to 12 mg and 0.95 mg, 

DESIGN AND respectively (Figure 1). A major reason for the decrease in smoke 

COMPOSITION yields is the wide acceptance of filter cigarettes. Their use steadily 

increased in America from 0.56 percent of all cigarettes smoked in 

Cigarettes With 1950 to 19 percent in 1955, 51 percent in 1960, 82 percent in 1970, 

Filter Tips 92 percent in 1980, and more than 97 percent since 1993 (Figure 2) 

(Hoffmann and Hoffmann, 1994b; U.S. Department of Agriculture, 1993). 

Most filter tips (15 to 35 mm) are made of cellulose acetate; only a low 

percentage of cigarettes are made with composite filters of cellulose acetate 

with charcoal. Since about 1968, increasing proportions of the cellulose 

acetate filter tips are perforated with one or more lines of tiny holes placed 

near the middle of the filter tow. Today up to 50 percent of all cigarette 

filter tips in the United States have various degrees of perforations. The 

conventional filter cigarettes are acceptable to consumers with a maximal 

draw resistance of up to about 130 mm water column (Kiefer and Touey, 

1967). The filters reduce primarily the smoke yields of particulate matter 

and thus the nonvolatile smoke constituents. The efficiency of cellulose 

acetate filters for total particulate matter (TPM) removal can be increased by 

reducing the diameter of the filaments without increasing the draw resistance 

(Table la) or by using a longer filter tip (Table lb). In the mainstream smoke 

of the U.S. blended cigarette with a pH below 6.3 to 6.5, more than 90 percent 

of the nicotine is present in the particulate matter as a salt with organic acids 

(Kiefer and Touey, 1967; Brunnemann and Hoffmann, 1974). 

Conventional cellulose acetate has the capability to selectively reduce 

some of the volatile and semivolatile compounds in the smokestream, 

especially when the filter is treated with certain plasticizers, such as glycerol 

triacetate. Some of the volatile smoke constituents that are ciliatoxic agents, 

such as acrolein, are removed selectively, even beyond the reduction of 

TPM, by retention on such treated filter tips. Phenols and cresols, a group 

of semivolatiles, also are removed selectively up to 80 to 85 percent, as are 

the highly carcinogenic dialkylnitrosamines, of which up to 75 percent can 

be retained on cellulose acetate filters (George and Keith, 1967; Brunnemann 

and Hoffmann, 1977). 

Filter tips with perforations allow dilution of the smoke with air. 

Moreover, drawing puffs through perforated filter cigarettes reduces the 

velocity of the air drawn through the burning cone. As a result, less of the 

18 
1 

Chapter 3 

Figure 2 

Percentage of all U.S. cigarettes with filter tips 

Source: US.Department of Agriculture, 1994. 

inner core of the burning cone is depleted of oxygen, and thus the levels 

of carbon monoxide, hydrogen cyanide, and some other volatiles are 

selectively reduced in the smoke of cigarettes with perforated filter tips 

(Figure 3) (National Cancer Institute, 1977). Furthermore, the lower velocity 

of the generated smoke increases the efficiency of the filter. However, the 

tumorigenicity of the resulting tar does not change compared with that of 

the tar of a conventional, nonperforated cellulose acetate filter cigarette 

(National Cancer Institute, 1977). In principle, the smoke of a cigarette 

can be diluted to an unlimited degree by air; however, the consumers’ 

nonacceptance of these cigarettes is the limiting factor. 

The use of charcoal particles in one of two or three sections of a filter 

tip, or sprayed onto the cellulose acetate, also offers the opportunity to 

selectively reduce certain volatile smoke constituents, such as the ciliatoxic 

hydrogen cyanide, acetaldehyde, and acrolein (National Cancer Institute, 

1977; Tiggelbeck, 1968). However, replacing one section of the filter tip 

with charcoal also leads to less reduction of TPM than can be achieved with 

19 
Smoking and Tobacco Control Monograph No. 7 

Table la 

Effect of filament diameter on filter efficiency" 

Approximate Pressure Drop Tar Removed 

Filament Diameter (p) (mm of H,O) (percent) 

22 55.7 30 

20 55.7 33 

17 53.1 36 

14 55.7 38 

12.6 53.1 43 

Table 1b 

Effect of filter length on efficiencyb 

Filter Length Pressure Drop Tar Removed 

(mm) (mm of H,O) (percent) 

15 42 26.2 

20 57 33.3 

25 71 39.7 

30 85 45.5 

35 99 50.8 

a Cellulose acetate, 17 mm in length, 25-mm circumference. 

Cellulose acetate, 24.6-mrn circumference. 

Key: p = micron (lo4meter);H,O = water. 

Source: Kiefer and Touey, 1967. 

a filter tip of the same length but made entirely of cellulose acetate (Figure 4) 

(Brunnemann et al., 1990). Charcoal-containing filter tips are efficient in 

selectively reducing certain volatile aromatic hydrocarbons, such as benzene 

and toluene, from the smoke of the early puffs; yet, they release these 

hydrocarbons during the later puffs (Brunnemann et al., 1990). 

Today, more than 70 percent of all cigarettes sold in Japan have 

charcoal-containing filter tips (Wynder and Hoffmann, 1994). Only a few 

percent of the cigarettes sold in the United States have such filters. Although 

more Japanese men smoke comparable numbers of cigarettes per day than 

American men do and the smoke yields per cigarette in Japan are similar 

to those in the United States, Japanese men have a significantly lower lung 

cancer incidence rate (Wynder and Hoffmann, 1994; Wynder et al., 1992). 

Among other factors, the lower yields of ciliatoxins, such as acrolein and 

hydrogen cyanide, in the smoke of cigarettes with charcoal filter tips may 

' be partly responsible for the lower lung cancer rate in Japan. 

20 
Chapter 3 

Figure 3 

Regression lines for all the investigated smoke components 

80 

70 

60 

n

CI

C 

g 50 

a 

U 

v 

C 

0 

-s 40

0

3 

'c1 

z 

2 30 

a

F 

20 

10 

0 10 20 30 40 50 60 70 

Dilution (percent) 

Key: CO = carbon monoxide; tot. ald. = total volatile aldehydes; NO = nitrogen oxide; H,O = water; 

CO, = carbon dioxide; HCN = hydrogen cyanide. 

Source: Norman, 1974. 

21 
Smoking and Tobacco Control Monograph No. 7 

Figure 4 

Filtration of smoke constituents 

15-mm Single Filters 

ViSCOSe Acetate Paper 

loo+ loo+ 

loo75 

0al 

a 50 75[ 50 

n 251 

” 

f -

F C A P N 

2 

F C A P N F C A P N 

Compound 

25t J 

Paper/Carbon AcetateKarbon Bonded Carbon (a 1 0 0 7 

- 75 

-

1.001- 0

50 

25 -

-

F C A P N F C A P N F C A P N 

25 

Compound 

251: 

I 

-1

7.5-+ 7.5-mm Dual Filters 

Acetate + Paper Acetate + Paper/Carbon Acetate I + Paper/Carbon loom 75 ;Iy501 

25 

w 

l 25 E 

F C A P N F C A P N F C A P N 

Compound 

Acetate + Bonded Carbon Acetate + Acetate/Carbon Viscose + Bonded Carbon 

100 

50 

25 2575E 

F C A P N F C A P N 

Compound 

Key: F = formaldehyde; C = hydrogen cyanide; A = acrolein; P = total phenols; N = nicotine. 

Source: Williamson et al., 1965. 

22 
Chapter 3 

I 

Cigarette Paper With increasing permeability, porous cigarette papers significantly 

reduce tar, carbon monoxide, and nitrogen oxides but not low-molecularweight gas phase components in the smokestream. Perforated cigarette 

paper also significantly reduces hydrogen cyanide, whereas nicotine 

reduction is less (National Cancer Institute, 1977) (Figure 5). In a recent 

study it was found that porous cigarette paper reduces not only smoke yields 

of carbon monoxide and tar but also of volatile nitrosamines, TSNAs, and 

benzo(a)pyrene (BaP) (Brunnemann et al., 1994). However, the reduction 

Figure 5 

Percentage change in smoke yield and composition with perforated, 0.5 percent 

citrate paper 

0 

-\ 

'\ Nicotine 

\ 

\ 

-1 0 "\ \ 

\ 

Q, 

w \

E 

m 

c 

-20 

Q)

w 

m ----- c,

E 

Q) \ Tar

2 

Q, -30 n 

40 

Puff Count 

9.0 9.1 9.3 9.5 9.7 9.8 9.9 10.0 

I I I I I I I I I I 

0 40 80 120 160 200 

CORESTA Permeability (cc/min x cm* x cbar) 

Key: NO = nitrogen oxide; CO = carbon monoxide. 

Source: Owens. 1978. 

23 
Smoking and Tobacco Control Monograph No. 7 

of TSNAs and BaP is not selective. On a gram-to-gram basis, the tars obtained 

from cigarettes with high-porosity paper still have the same tumorigenic 

activity as does the tar from control cigarettes that have conventional 

cigarette paper (National Cancer Institute, 1977). 

Reconstituted Reconstituted tobacco (RT) was first used after World War I1 as a 

Tobacco binder for cigars and until the beginning of the 1960’s on a limited 

scale for cigarettes (Halter and Ito, 1979). The interest in RT grew with 

the observation that cigarettes made exclusively from RT delivered lower 

smoke yields of tar, phenols, and BaP. On a gram-to-gram basis, this tar had 

significantly lower tumorigenicity on mouse skin and in the respiratory tract 

of hamsters (Wynder and Hoffmann, 1965). In 1974 the Research Institute 

of the German Cigarette Industry reported that forced exposure of Syrian 

golden hamsters to the smoke of cigarettes filled exclusively with RT gave 

significantly lower tumor incidence in the upper respiratory tract of the 

animals than treatment with the smoke of a blended cigarette containing 

only lamina of bright, burley, and oriental tobacco (Dontenwill, 1974). 

Reconstituted tobacco, or homogenized sheet tobacco as it is sometimes 

called, is a paperlike sheet approaching the thickness of tobacco laminae. 

RT is made from tobacco dust, fines, and particles from ribs and stems; 

various additives may be incorporated. The process for making RT can be 

divided into four general classes. The first two relate to the papermaking 

process; the third involves a slurry; and the fourth is based on the 

preparation of a tobacco paste with rollers using water or low-boiling 

solvents. For the papermaking process, a mixture of fines, midribs, and 

sometimes tobacco stems is broken up and extracted with water. The extract 

is concentrated by evaporation. The insoluble residue is macerated further, 

and the resulting material is formed into a paperlike web on a papermaking 

machine. The web is dried and then impregnated with the concentrated 

extract; this web is then further dried and cut. The shredded material is 

added to the tobacco blend. Because the water extract of the tobacco 

contains nicotine and this extract is added in concentrated form to the 

tobacco web, this process has been considered a “nicotine-enriching process.” 

In one papermaking process, cellulose fiber is added to increase the filling 

power and stability of the resulting RT. 

In making RT by the slurry process, dry tobacco materials are finely 

divided and often mixed with small amounts of adhesive, then suspended 

in water. The resulting slurry is placed on a metallic band on which it is 

dried. The resulting sheet is shredded and added to the tobacco blend. In 

the rolling process, only small amounts of water are added to the mixture of 

tobacco fines, dust, and finely powdered ribs; this paste is placed onto rollers 

with different speeds, resulting in a sheet with limited filling power and 

tensile strength. 

The potential to produce RT in various forms with different densities 

and filling powers and thereby to modify the tumorigenicity of tars and 

whole smoke encouraged the National Cancer Institute (NCI) in the 1970’s 

to explore the use of various types of RT for recommendations of a less 

24 
Chapter 3 

hazardous cigarette. The results documented that RT, especially RT 

resulting from the paper process with cellulose fiber as an additive, offered 

an opportunity to significantly reduce the cigarette smoke yields of tar, 

nicotine, phenols, and PAHs, as well as the tumorigenicity of the resulting 

tar. The most encouraging results were achieved with RT resulting from 

the paper process using only tobacco stems (Table 2). 

Today, most blended U.S. cigarettes contain 20 to 30 percent RT, which 

is also now widely used in Europe, Canada, and Japan. 

Puffed, Expanded, In the early 1970’s a new tobacco preparation was introduced for 

and Freeze-Dried the blended cigarette, that of “puffed,” “expanded,” or “freezeTobaccos dried” tobacco. Using these materials, less tobacco is required 

to fill a cigarette. The principle is to expand the tobacco cell walls by quick 

evaporation of water and other vaporizable agents. This causes a rapid 

pressure increase in the cells by heat and/or the reduction of external 

pressure. 

Table 3 summarizes the smoke yields of experimental cigarettes made 

exclusively from puffed, expanded, or freeze-dried tobaccos. The smoke data 

are compared with those from the smoke of the control cigarette. The tars 

from the smoke of cigarettes made from expanded and freeze-dried tobaccos 

were significantly less tumorigenic than tar from the control cigarettes 

(National Cancer Institute, 1980). 

Table 2 

Smoke yields of cigarettes made from reconstituted tobacco (RT) by paper 

processes and from control cigarettes 

RT RT 

Components Stems Only Blend Control 

Weight (mg) 1,011.o 1,060.0 1,226.0 

Tar (mg) 11.3 11.7 25.9 

Nicotine (mg) 0.2 0.7 1.7 

Carbon Monoxide (mg) 11.9 11.8 16.1 

NO, (P.9) 586.0 343.0 367.0 

Hydrocyanic acid (pg) 73.5 81.9 201 .o 

Acetaldehyde (pg) 1,027.0 948.0 1,065.0 

Acrolein (pg) 99.0 105.0 109.0 

Benz(a)anthracene (ng) 13.1 9.8 46.3 

Benzo(a)pyrene (ng) 8.9 7:4 27.8 

Key: NO, = N (>95 percent) + NO, (<5percent). 

Source: National Cancer Institute, 1976a and 1976b. 

25 
Smoking and Tobacco Control Monograph No. 7 

Table 3 

Smoke analysis of cigarettes made from puffed, expanded, and freeze-dried tobaccos 

and from control cigarettes 

Smoke Puffed Expanded Freeze-Dried 

Component Tobacco Tobacco Tobacco Control 

Carbon Monoxide (mg) 9.33 11.80 12.30 18.00 

Nitrogen Oxides (pg) 247.00 293.00 235.00 269.00 

Hydrogen Cyanide (pg) 199.00 287.00 234.00 41 3.00 

Formaldehyde (pg) 20.70 21.70 33.40 31.70 

Acetaldehyde (pg) 814.00 720.00 968.00 986.00 

Acrolein (pg) 105.00 87.70 92.40 128.00 

Tar (mg) 15.60 18.20 16.30 36.70 

Nicotine (mg) 0.78 0.74 0.82 2.61 

Benz(a)anthracene (ng) 13.70 11.80 15.30 37.10 

Benzo(a)pyrene (ng) 11.80 8.20 9.20 28.70 

Source: National Cancer Institute, 1976b. 

The use of puffed, expanded, or freeze-dried tobacco, together with the 

use of filter tips and reconstituted tobaccos, has had a major impact on the 

amounts of leaf tobacco needed per average U.S. cigarette. In about 1950 

1,230 mg of leaf tobacco were required for one cigarette, whereas only 

785 mg were needed in 1982 (Grise, 1984). 

Physical As the length of a cigarette increases, there is more opportunity for air 

Parameters to enter through the paper and for certain gaseous components, for 

of Cigarettes example, carbon monoxide and hydrogen cyanide, to diffuse out of the 

paper into the environment. Assuming that all other factors remain 

Length the same and only the length of the cigarette increases, there will be 

a higher smoke yield of tar and nicotine because more tobacco is burned 

(Moore and Bock, 1968). In the past, it was claimed that tobacco absorbs 

only slightly less of the smoke particulates than a cellulose acetate filter tip 

(Dobrowsky, 1960). This may have been true in the early 1960’s, but modern 

cellulose acetate filter tips are more efficient in retaining smoke particulates 

than the tobacco column of a cigarette. 

Circumference With the packing density remaining constant, a decrease in 

circumference of a cigarette reduces the amount of tobacco available for 

burning. As a result, tar and nicotine yields in the smokestream are reduced 

(Table 4) as are the yields of carbon monoxide and several other volatile 

smoke constituents (DeBardeleben et al., 1978). 

26 
Chapter 3 

Table 4 

Effect of cigarette circumference on tar and nicotine in mainstream smoke 

Delivery (mg) 

Circumference (mm) Tar Nicotine ~ 

26 23.3 1.56 

25 21.5 1.46 

24 19.9 1.35 

23 18.2 1.21 

Source: DeBardeleben et a/., 1978. 

Tobacco Cut Studies have shown that modifymg tobacco from fine to coarse cut 

causes the number of puffs per cigarette to increase (DeBardeleben et al., 

1978). In general, cigarettes that are filled with a more coarsely cut tobacco 

burn less efficiently than those made with fine-cut tobacco. One report, 

comparing the smoke of cigarettes filled with coarse-cut tobacco (1.27 mm) 

with smoke from cigarettes made with fine-cut tobacco (0.42 mm), 

showed only slight differences in smoke yields (Spears, 1974). However, 

a comparison of tars from cigarettes with given tobacco cut at rates of 

20, 30, or 50 cuts per inch (1.27, 0.85, and 0.51 mm, respectively) showed 

in a bioassay that the finer the cut of the tobacco, the lower the 

tumorigenicity of the resulting tar (Wynder and Hoffmann, 1965). 

Packing Density Increasing the mass of the tobacco in a cigarette-increasing the 

packing density-causes yields of tar and nicotine in the smoke to rise. 

However, packing more than 1.O g of tobacco into an 85-mm cigarette causes 

the yields of tar and nicotine in the smoke to decrease, most likely because 

of increased retention by the tobacco acting as a filter (Figure 6). 

Tobacco Pesticides Since 1969 the use of chlorinated pesticides has been banned 

in the cultivation of tobacco in the United States. As a result, l,l,l-trichloro2-(4,4'-dichlorodipheny1)ethane(DDT) and l,l,-dichloro-2-2(4,4'- 

dichlorodipheny1)ethane (DDD) in tobacco and in cigarette smoke have 

drastically decreased. In the tobacco of a cigarette made in 1965, 13.4 ppm 

DDT and 20.2 ppm DDD were measured, and in the tobacco of the leading 

cigarette brand made in 1993, only 0.02 ppm DDT and 0.013 ppm DDD 

were detected, a decrease of more than 98 percent (Djordjevic et al., 1995). 

The small amounts of residual DDT and DDD in more recently produced 

cigarettes appear to originate from imported tobaccos used for blended 

cigarettes. 

It was reported in 1981 that U.S. tobacco contains 250 ppb of the 

carcinogenic N-nitrosodiethanolamine (NDELA). This nitrosamine is formed 

by N-nitrosation of the secondary amine diethanolamine during tobacco 

27 
Smoking and Tobacco Control Monograph No. 7 

Figure 6 

Effed of cigarette weight/packing density on particulate matter 

+ 

Key: TPM = total particulate matter. 

Source: DeBardeleben et a/., 1978. 

28 
Chapter 3 

processing. The major source of diethanolamine in tobacco in 1981 was 

the sucker growth inhibitor MH-30, which is the diethanolamine salt of 

maleic hydrazide (Brunnemann and Hoffmann, 1981). Because of the ban 

on MH-30 for tobacco treatment, NDELA levels have decreased to less than 

100 ppb in cigarette tobacco (Brunnemann and Hoffmann, 1991). The 

remaining NDELA may be at least partially due to the contamination with 

diethanolamine from packaging materials. 

Several pesticides are still being used on tobacco; these include 

insecticides, fumigants, and insect growth regulators (Benezet, 1989). 

There is only limited knowledge about the residues of these agents on 

cigarette tobacco and about their role during smoking. 

Additives In April 1994, the major U.S. cigarette companies released a list of 

599 additives used in the manufacture of cigarettes (Tobacco Reporter 

Staff, 1994). Little is known about the fate of such additives during the 

smoking of cigarettes. An exception is menthol, which amounts to less 

than 2.5 mg in U.S. mentholated cigarettes (Perfetti and Gordin, 1985). 

Menthol is not carcinogenic in rodents (National Cancer Institute, 1979), 

nor does this readily volatilized compound give rise to measurable amounts 

of carcinogenic hydrocarbons, including BaP, during the smoking of 

cigarettes aenkins et al., 1970). 

The list of additives also contains inorganic salts, such as ammonium 

and potassium carbonates, and bicarbonates. These additives possibly 

increase the pH of cigarette smoke. Beyond pH 6.0, cigarette smoke contains 

increasing amounts of unprotonated nicotine; with smoke pH at 6.9, about 

10percent of the nicotine is present in the smoke in free form; at pH 7.85 

this rises to 50 percent (Brunnemann and Hoffmann, 1974). The free 

nicotine is present predominantly in the vapor phase of the smoke and is 

more quickly absorbed through the oral mucosa than nicotine in salt form 

(Armitage and Turner, 1970). Data are urgently needed for examining the 

change in pH of the smoke of cigarettes with additives. 

Although most additives that are used as flavor-enhancing agents are 

sprayed onto tobacco in milligram amounts and may therefore generate at 

most microgram amounts of toxic or tumorigenic agents in the smoke, it is 

nevertheless important to document the fate of such compounds when they 

are added to cigarettes, cigars, or pipe tobacco. 

Tobacco Blend Most U.S. cigarettes manufactured worldwide are blended cigarettes. 

The composition of the tobacco blend has a major influence on the pH, 

toxicity, and tumorigenicity of the smoke. Many tobacco lines are available, 

including about 60 species and about 1,000 different tobacco varieties (Tsn, 

1972). The wealth of this source permits the manipulation of the tobacco 

plant and its components and leads to selective use of those portions of 

the plant that enhance or reduce specific agents in the smoke. This is then 

reflected in the toxicity and/or carcinogenicity of the smoke. For example, 

there are flue-cured tobacco lines that contain 0.2 to 4.75 percent nicotine 

and burley lines with 0.3 to 4.58 percent nicotine (Chaplin, 1975). 

29 
Smoking and Tobacco Control Monograph No. 7 

Furthermore, flue-cured tobacco leaves harvested from the lowest stalk 

position contain 0.08 to 0.65 percent nicotine, whereas those from the 

highest positions contain between 0.13 and 4.18 percent nicotine (Tso, 

1977). The resulting smoke differs widely in its concentration of toxic and 

tumorigenic agents (Hoffmann and Hoffmann, 1994a). Another example 

is the BaP content of the smoke generated from leaves harvested from the 

lowest stalk position, which ranges between 14.9 and 18.2 ng per cigarette, 

contrasted with BaP in the smoke from the leaves of the highest stalk 

position, which ranges between 23.2 and 35.2 ng per cigarette (Rathkamp 

et al., 1973). 

The first comparative study of the smoke of cigarettes made exclusively 

from bright, oriental, burley, and Maryland tobacco was published by 

Wynder and Hoffmann (1963). The BaP levels in the smoke per cigarette 

(without filter tip) were 53, 44, 24, and 18ng, respectively. The tars from the 

smoke of cigarettes made with bright and oriental tobaccos were significantly 

more tumorigenic than the tars from burley and Maryland tobaccos (Wynder 

and Hoffmann, 1963). A large-scale study by NCI confirmed the observation 

that the smoke of burley tobacco is lower in BaP and other carcinogenic 

agents than the smoke of bright tobacco and that the tar has less tumorigenic 

activity than the tar from bright tobacco (National Cancer Institute, 1980). 

During the past three decades, the nitrate content of the U.S. cigarette 

blend increased from 0.3 to 0.5 percent to 0.6 to 1.35 percent (U.S. 

Department of Health and Human Services, 1981; Fischer et al., 1990). 

During smoking, the nitrates in tobacco give rise to nitrogen oxides that 

scavenge C,H-radicals and thereby inhibit the pyrosynthesis of carcinogenic 

PAHs; at the same time, nitrogen oxides are involved in the formation of 

nitrosamines from secondary and tertiary amines in tobacco (Rathkamp and 

Hoffmann, 1970; Hoffmann et al., 1994). The result is that today the smoke 

of the U.S. blended cigarette has lower concentrations of PAHs but higher 

concentrations of N-nitrosamines than the smoke of the U.S. blended 

cigarette three decades ago. Figure 7 shows the decrease per cigarette of 

BaP from 50 ng in 1965 to 20 ng in 1992 and the concomitant increase of 

the levels of the organ-specific lung carcinogen 4-(methylnitrosamino)-l-

(3-pyridyl)-l-butanone(NNK)from 110 ng in the late 1970's to 176 ng in 

1992. These data pertain to the smoke of a leading United States nonfilter 

cigarette. NNK is formed from nicotine during tobacco processing and 

smoking (Hoffmann and Hoffmann, 1994a). In laboratory animals, 

carcinogenic PAHs induce primarily squamous cell carcinoma, whereas 

NNK elicits mainly adenocarcinoma in the peripheral lung. One major 

reason for the steep ascent of lung adenocarcinoma incidence in cigarette 

smokers in the United States compared with the more modest rise of 

squamous cell carcinoma may lie in the more intense smoking of the lownicotine cigarette. The deeper inhalation of the smoke from these cigarettes 

has led to higher yields of NNK and lower yields of BaP in the smoke of the 

more recent cigarettes. This modification has created a different profile of 

smoke carcinogens that is likely reflected in the changed tumor morphology 

that has emerged since the 1960's (Wynder and Hoffmann, 1994). 

30 
Chapter 3 

Figure 7 

BaP and NNK in mainstream smoke of a leading U.S. nonfilter cigarette, 1959-1 992 

80 200 

60 150 

n n

ul 

C

-

ul 

40 100 ;

C 

n 

to z rn z 

20 50 

0 I I I I I I I 0 

1955 1960 1965 1970 1975 1980 1985 1990 1995 

Year 

Source: Hoffmann and Hoffmann, 1994a. 

SUMMARY Table 5 indicates the potential roles that filter tips, perforated filter tips, 

cigarette paper, reconstituted tobacco, expanded tobacco, and an increase 

of the share of bright and burley tobacco in the cigarette blend have in 

affecting the smoke yields of selected toxic and tumorigenic agents. These 

observations have largely been taken into account with respect to the 

manufacture of blended U.S. filter cigarettes, which accounted for 97 percent 

of all cigarettes sold on the U.S. market in 1993. The result is a cigarette 

that delivers smoke with generally lower toxicity and tumorigenicity than 

products that were smoked 40 years ago. However, all the measurements 

on which this evaluation are based were obtained by standardized machine 

smoking with parameters that are not in line with the real practices of men 

and women who smoke the modern, low-yield, filter-tipped cigarettes 

(Russell, 1980; Herning et al., 1981; Kozlowski et al., 1982; Fagerstrom, 1982; 

Haley et al., 1985; Byrd et al., 1994). Is it thus safe to say that the modern 

cigarette is really less harmful? 

31 
Smokinn and Tobacco Control Monoarailh No. 7 

Table 5 

Changes in cigarette design and composition: Effects on smoke yields of selected toxic agents 

Smoke Perforated Cigarette Reconstituted Expanded Bright Burley 

Compound Filter Filter Paper Tobacco Tobacco Tobacco Tobacco 

Tar a e a a a b a 

Nicotine a e C a a C C 

PH NC NC NC NC NC d b 

co C a NC a a b d 

HCN NC a NC a a C C 

Volatile 

Aldehydes NC a NC a a b a 

Volatile 

Nitrosamines e e NC a a e b 

Phenol e e NC a a b a 

PAHs a e NC a a b a 

TSNAs a e NC f f e b 

a Significant decrease. 

Trend for increase. 

Can increase, can decrease. 

Trend for decrease. 

e More than a 50-percent decrease. 

’Unknown. 

Key: CO = carbon monoxide; HCN = hydrocyanic acid; PAHs = polynuclear aromatic hydrocarbons; 

TSNAs = tobacco-specific N-nitrosamines; NC = no significant change. 

How can the human risk from cigarette smoking truly be assessed? 

Should we not above all remember that the only way to prevent smokingrelated diseases is abstinence from tobacco? Meanwhile, millions of smokers 

in the United States and worldwide continue to smoke cigarettes and to use 

other forms of tobacco because of their dependence on nicotine. Smoking 

cessation efforts have had success for many but are not likely to stem the tide 

of an enormous epidemic of smoking-related diseases that will be seen in the 

coming decades in those parts of the world that have hardly begun to tally 

the incidence and mortality from tobacco-related illness. 

In the United States, we have today several sensitive techniques that can 

assist in determining uptake and even an individual’s capacity for activating 

vs. detoxifymg xenobiotics, such as the toxins and carcinogens from tobacco 

smoke (Bryant et al., 1988; Santella et al., 1992; Melikian et al., 1993; Hecht 

et al., 1994), but these sophisticated methods of risk assessment are research 

tools that for now do little to guide the consumer. One may agree with the 

content of an editorial published in the New York Times (1989) that read: 

“Obviously, no smoking is better than smoking, but the best should not be 

32 
Chapter 3 

the enemy of the good. There is a strong social case for.encouraging 

manufacturers to develop safer cigarettes that will sell.” If we take this 

premise as a realistic approach to the tobacco and illness dilemma in our 

Nation, how can our regulatory agencies effectively protect the consumer 

and on what type of measurement should risk assessment from cigarette 

smoking be based? This is the question to be resolved. The authors hope 

that presentation of some historical background will assist with this aim. 

QUESTION-AND-ANSWER SESSION 

DR. HENNINGFIELD: Dr. Hoffmann, the influence of some parameters, 

such as increasing puff quantity, would be pretty obvious for their impact; 

you would take in more smoke. But what about the factor of changing the 

intensity of a puff? For example, the FTC method uses 35 mL over 2 seconds, 

or say about 18mL per second. What would be the impact of tripling the 

intensity by going to, say, 60 mL per 1second? 

DR. HOFFMANN: This has been done by various groups, including 

Dr. Benowitz, Dr. Auston, and Dr. Ogg. All have shown that when you 

smoke more intensely (I think one report makes up to four or five puffs 

per minute, with puff volumes up to 55 mL), you obviously increase the 

smoke yields for cigarette smoke; based on epidemiological observations, 

but you inhale deeper. 

Now, this is reflected in the yield of nicotine respectively as one of its 

major metabolites. And in fact, R.J. Reynolds Tobacco Company has recently 

shown a very low yielding cigarette. They determined 90 percent of all 

metabolites, and I think the results are in here. They have shown that with 

the very low yielding cigarettes, the smoker inhales more than one would 

expect from machine smoking data, based on the nicotine metabolites. 

Machine smoking data may be all right for the cigarette without a filter 

tip, but based on all these studies (I think there are eight all total), the 

smoker of a low yielding cigarette inhales deeper and takes more puffs, 

smokes more intensely. 

DR. RICKERT: Dr. Hoffmann, I think you were intimately involved in the 

NCI’s less hazardous cigarette program a number of years ago. Why was 

that program abandoned? 

DR. HOFFMANN: The timing was not right-I do not know the details. 

I work in the laboratory, and that is outside the field. It was purely politics. 

DR. HARRIS: Dr. Hoffmann, you presented trends in some cigarette smoke 

components over time. What do you know, if anything, about gross 

characteristics of cigarette smoke, such as the trends in the pH of American 

cigarette smoke or in the oxidation reduction potential of smoke? 

DR. HOFFMANN: The pH has increased slightly; it is slightly higher in 

filtered cigarettes, in perforated filter cigarettes, and in RT. 

33 
Smoking and Tobacco Control Monograph No. 7 

There has been a slight increase in unprotonated nicotine, but it is a 

minor difference, because it is still a blended cigarette. If you smoke a 

French cigarette, which are the black or burley type cigarettes, they have 

a pH of 7.5, or 40 percent of the nicotine is unprotonated; whereas, in our 

blended U.S. cigarettes, less than 5 percent is unprotonated. As an English 

study by Turner and others has shown, when you have unprotonated 

nicotine, most of it has a quicker result to the mucous membrane, especially 

of the oral cavity. In other words, when you have unprotonated nicotine, 

not in salt form but in free base, most of it is in the water phase, and 

therefore it is absorbed more quickly by the surface of the bronchial 

epithelium or the oral cavity. 

Therefore, you would rarely see a Frenchman taking as deep inhalations 

as a smoker of a blended cigarette with an active filter tip. You watch a 

Paris cab driver and you will see that they never inhale; he just dangles the 

cigarette on the side of his mouth, because he would get a tremendous 

nicotine kick if he inhaled. 

DR. HARRIS: Does the protonation state of nicotine, whether it is protonated 

or free base, affect the measurement method of nicotine as currently used by 

the FTC? 

DR. HOFFMANN: No, the pH is not measured. I do not see the need because 

so far, in our U.S. blended cigarettes, there are no major differences. That 

may change, but at present, it is not. 

DR. HUGHES: I noticed over time that the tar and nicotine yields have 

changed somewhat. What is your opinion about how feasible it is, using 

existing techniques, to change that ratio? 

DR. HOFFMANN: The first study was performed in the United Kingdom 

by Russell. It demonstrated that the ratio of tar to nicotine, which was 

originally 100 to 6, has changed to 100to 10. We see this in low yielding 

cigarettes. In other words, the nicotine is not reduced to the same extent 

that the tar is reduced. 

DR. HUGHES: And how feasible would it be for the manufacturers to 

deliberately change that ratio at this point? 

DR. HOFFMANN: They can do it easily by changing the tobacco variety, 

which is high in nicotine. We have heard about genetic engineering for 

a tobacco variety that is very high in nicotine. So that is possible. I mean, 

the manufacturer has everything in his hand to have high nicotine and 

low tar or vice versa. 

In fact, for a brief time, there was a cigarette on the market that was free 

of nicotine. The nicotine was extracted from the tobacco with supercritical 

fluid transaction, and the tobacco was then used for cigarettes. So, the 

tobacco industry has a whole spectrum from high- to low-nicotine yield. 

That depends on what the consumer requests. 

34 
Chapter 3 

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Heming, R.I., Jones, R.T., Bachman, J., Mines, A.H. 

Puff volume increases when low-nicotine cigarettes 

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Ed.) 283(6285): 187-189, 1981. 

35 
Smoking and Tobacco Control Monograph No. 7 

Hoffmann, D., Brunnemann, K.D., Prokopczyk, B., 

Djordjevic, M.V. Tobacco-specific N-nitrosamines 

and Areca-derived N-nitrosamines: Chemistry, 

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Hoffmann, D., Hoffmann, I. Recent developments in 

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80(4): 429-434, 1985. 

Jenkins, R.W.J., Newman, R.H., Chavis, M.K. Cigarette 

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1970. 

Kiefer, J.E., Touey, G.P. Filtration of tobacco smoke 

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1967, pp. 545-575. 

Kozlowski, L.T., Rickert, W.S., Pope, M.A., Robinson, 

J.C., Frecker, R.C. Estimating the yields to smokers of 

tar, nicotine, and carbon monoxide from the “lowest 

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Melikian, A.A., Prahalad, A.K., Hoffmann, D. Urinary 

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36 
Chapter 3 

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ACKNOWLEDGMENTS The authors greatly appreciate the editorial assistance of 

Ilse Hoffmann and Jennifer Johnting. The authors' work cited in this article 

was supported by NCI grant CA-29580. 

37 
BLANK PAGE 
ChaDter 4 

Attitudes, Knowledge, and Beliefs About 

Low-Yield Cigarettes Among Adolescents and 

Adults 

Gary A. Giovino, Scott L. Tomar, Murli N. Reddy, John P. Peddicord, 

Bao-Ping Zhu, Luis G. Escobedo, and Michael P. Eriksen 

INTRODUCTION Per capita consumption of cigarettes in the United States increased 

rapidly from 1900 to 1963 (Miller, 1981; U.S. Department of Health and 

Human Services, 1989); however, since the January 1964 release of the 

first Surgeon General’s report on smoking (US. Department of Health, 

Education, and Welfare, 1964), cigarette consumption has been declining 

(Miller, 1981; U.S. Department of Agriculture, 1987 and 1994). In 1994 per 

capita consumption was about the same as during World War I1 (Miller, 1981; 

U.S. Department of Agriculture, 1994). However, the prevalence of smoking 

was slightly higher in the 1940’s (Centers for Disease Control and Prevention, 

1994a; U.S. Department of Health and Human Services, 1988), indicating 

that smokers in the 1990’s consumed more cigarettes per day than did 

smokers in the 1940’s (Harris, 1994; U.S. Department of Health and 

Human Services, 1980). 

Falls in per capita consumption of cigarettes seem linked to health 

concerns. For example, in the early 1950’s, scientific and popular articles 

led to increasing concern about smoking-related cancers. American and 

British studies provided a scientific foundation for the mounting health 

concerns (Doll and Hill, 1950 and 1952; Levin et al., 1950; Wynder and 

Graham, 1950). Articles such as “Cancer by the Carton,” published in 

the Reader’s Digest (Norr, 1952), also carried the message to many people 

(U.S. Department of Health and Human Services, 1989). 

One apparent result of these early health communications was the 

marked increase in the consumption of filter-tipped cigarettes. In the 1940’s 

few people smoked those varieties (U.S. Department of Agriculture, 1962), 

but by 1992 about 97 percent of cigarettes sold had filters (Figure 1)(Federal 

Trade Commission, 1994). Switching to filtered cigarettes was promoted by 

slogans such as “Kent with the micronite filter is smoked by more scientists 

and educators than any other cigarette” (Anonymous, 1985). 

The release of the first Surgeon General’s report on smoking was a 

major turning point in public perception of the health threat of tobacco 

(US. Department of Health, Education, and Welfare, 1964; U.S. Department 

of Health and Human Services, 1989). In response, cigarette companies 

began introducing cigarettes in the 1960’s and early. 1970’s that yielded, 

39 
.' I 

=I 

0 v) 0 

LD (v 

40 
Chmter 4 

by the Federal Trade Commission (FTC) method (Pillsbury et al., 1969), 

15 mg or less tar (Federal Trade Commission, 1994; Slade, 1989; Warner, 

1985). By 1992 these so-called milder cigarettes had captured about 

69 percent of the market (Federal Trade Commission, 1994). 

The lower tar cigarettes were accompanied by advertisements such 

as the following: 

Vantage is changing a lot of my feelings about smoking. I like 

to smoke, and what I like is a cigarette that is not limited on 

taste. But I am not living in an ivory tower. I hear the things 

being said about high tar smoking as well as the next guy. So, 

I started looking for a low tar smoke that had some honest-togoodness taste (Anonymous, 1977). 

It is believed that the Vantage advertisements targeted “intelligent” 

smokers (Pollay, 1990). 

Since 1974, FTC has collected data on advertising and promotion of 

cigarettes yielding 15 mg or less tar (Figure 2) (Federal Trade Commission, 

1994). As pointed out by Davis (1987), for many years the proportion of 

advertising and promotional expenditures for lower tar cigarettes exceeded 

Figure 2 

Domestic market share and proportion of total advertising and promotional expenditures 

related to cigarettes yielding 51 5 rng tar, by year: United States, 1975-1 992 

8o1 

70-

60 -

/ -------e---

50 CI

C 

aa2 40 

aa 

n 

30 f 

0‘ 

20 - 0 

## promotional expenditures 

10- -- Domestic market share 

0 I I I I I I I I 1 I I I I I I I I I 

1975 1977 1979 1981 1983 1985 1987 1989 1991 

Year 

Source: Federal Trade Commission, 1994. 

41 
Smoking and Tobacco Control Monograph No. 7 

market share, suggesting an attempt to increase market share. As shown in 

Figure 2, the two proportions are converging. In 1992 lower tar cigarettes 

accounted for 69 percent of market share and 71 percent of advertising 

expenditures (Federal Trade Commission, 1994). 

One major purpose of the marketing of these varieties of cigarettes 

appears to have been to alleviate smokers’ health concerns (Pollay, 1990; 

Warner 1985). The advertisements seem to have achieved a large part of 

their goal. In 1993 a Gallup Organization poll posed the following question: 

“Besides selling the product, what message do you think cigarette advertising 

is trying to get across when it uses terms like low tar, low nicotine, or low 

yield?” (Gallup Organization, Inc., 1993, pp. 22). Fifty-eight percent of 

respondents (56 percent of smokers and 60 percent of nonsmokers) answered 

that the message indicates a positive health benefit, that is, that the brand 

is safer, healthier, less harmful, not as bad for you, or less cancerous (Gallup 

Organization, Inc., 1993). 

MONITORING Three national surveys helped shed light on the patterns in 

NATIONAL DATA attitudes, knowledge, and beliefs about low-yield cigarettes: 

the 1986 Adult Use of Tobacco Survey (AUTS), the 1987 National Health 

Interview Survey (NHIS) Cancer Control Supplement, and the 1993 Teenage 

Attitudes and Practices Survey (TAPS). The 1986 AUTS was a national 

telephone survey of approximately 13,000 Americans ages 17 years and 

older (Pierce et al., 1990). The nationally representative sample of the 1987 

NHIS included about 22,000 Americans ages 18years and older who were 

interviewed primarily in their homes (Schoenborn and Boyd, 1989). The 

1993 TAPS sample included about 13,000 people 10to 22 years of age 

who were contacted via telephone or in their homes (Centers for Disease 

Control and Prevention, 1994b). The 1993 TAPS included a cross-sectional 

component of persons 10 to 15 years of age in 1993 and a followup 

component of a cohort of persons first interviewed in 1989 who were 15 

to 22 years old in 1993 (Centers for Disease Control and Prevention, 1994b). 

There are difficulties in using the 1993 TAPS data to make prevalence 

estimates. Some participants lost to followup were more likely to be 

smokers in 1989, a phenomenon that would be likely to decrease the overall 

prevalence estimate (Centers for Disease Control and Prevention, 1994b). 

The data used for this report are not used to generate smoking prevalence 

estimates; rather, they look at characteristics of persons who reported that 

they were currently smoking. 

The 1986 AUTS and the 1987 NHIS questions used to determine tar 

levels assessed items such as brand name, filter vs. nonfilter, pack hardness, 

cigarette length, mentholation, and if the cigarette was regular, light, or 

ultralight. The tar level assigned is based on responses to the questions using 

FTC tables (Federal Trade Commission, 1985). The tar categories used for 

this report are (1)less than or equal to 6 mg, (2) 7 to 15 mg, and (3) 16 mg 

or more. (The actual cutpoints used here are 6.99 mg and 15.99 mg.) 

42 
Chapter 4 

SURVEY FINDINGS The percentage distribution of tar yield of the usual brand of 

cigarettes smoked among current smokers by sex and age is 

Use of Low-Tar shown in Figure 3. Female smokers were more likely to smoke 

or Light Cigarettes lower tar yield brands than men. Smokers 18 to 24 years of age 

were less likely to use the lower tar brands than smokers ages 25 to 44 or 45 

to 64. These patterns were similar to those found by the AUTS for both 

current and former smokers. 

With regard to race and ethnicity (Figure 4), white Americans who 

smoked in 1987 were more likely to smoke lower tar and nicotine 

cigarettes (76.8 percent) than Hispanics (67.8 percent) or black Americans 

(52.4 percent). Education is a strong correlate of smoking cigarette brands 

with 15 mg or less tar (Figure 4). Beginning with persons who have 

completed 9 to 11years of education, as education increased, smokers 

were more likely to smoke low-tar brands. 

In the 1993 TAPS, adolescents and young adults who smoked and 

usually bought their own cigarettes were asked what brands they smoked. 

Furthermore, they were asked, “Is the brand you smoke regular, light, or 

Figure 3 

Prevalence (by percent) of current smokers’ use of cigarette brands” with s15 mg tar, 

by sex and age: Ages 18 and older, United States, 1987 

100- 1 56 mg tar 7-15 mg tar I - AA~2 

80- 73.4 

78.8 

. _. . 73.5

- 62.6 

59.6 -

c 60-

Q) - 2 

40-

-

20-

-

0--

Male Female 18-24 25-44 45-64 65+ 

Sex Age (years) 

a Self-reported usual brand. 

Source: National Center for Health Statistics, 7987. 

43 
-- 

Smoking and Tobacco Control Monograph No. 7 

Figure 4 

Prevalence (by percent) of current smokers’ use of cigarette brandsa with 515 mg tar, 

by race and education: Ages 18 and older, United States, 1987 

s6 mg tar 7-15 mg tar 

87 8 

83.6 

801 76.8 

67 8 

I::200 

White Black Hispanic 0-8 9-11 12 13-15 16+ 

Race/Et hnicity Education (years completed) 

a Self-reported usual brand. 

Source: National Center for Health Statistics, 1987. 

ultralight?” Of note, “light” and “ultralight” are terms used in advertising 

and may not correlate precisely with tar and nicotine levels (Davis et al., 

1990). However, these are terms that smokers frequently use in describing 

the brands they smoke. 

There are two key findings from the TAPS data. First, among 10- to 

18-year-olds and 19- to 22-year-olds, females were more likely than males 

to smoke light and ultralight cigarettes (Figure 5). Very few males smoked 

ultralight cigarettes. Second, the proportion of males and females using these 

brands increased with age. This pattern among young persons (increasing 

use of light and ultralight brands with increasing age) is reflected in both 

the 1987 NHIS and the 1993 TAPS. 

The 1993 TAPS race and ethnicity findings are similar to those detected 

by the NHIS: White youth were most likely to smoke light cigarettes 

(52.6 percent), followed by Hispanic youth (44.5 percent), with much 

smaller proportions of black youth (15 percent) reporting use of these brands 

(Figure 6). Anecdotal evidence also indicates that African-American youth 

begin with higher tar cigarettes (Gallup International Institute, 1992). 

44 
Chapter 4 

Figure 5 

Prevalence (by percent) of use of light and ultralight cigarettes among current smokers,a 

by sex and age: Ages 10 to 22, United States, 1993 

67.3 Im Ultralights 0 Lights 1 

60 

52.6 

A7.. .-9 

27.4 

20 

10 

n 

Male Female Male Female 

10- to 18-Years-Old 19- to 22-Years-Old 

* Who usually buy their own cigarettes. 

Source: Centers for Disease Control and Prevention, 1993. 

In the 1993 TAPS, students were asked to rate how well they were doing 

in school; the categories used here were less than average, average, better 

than average, and much better than average. The percentage of young 

smokers who smoked light or ultralight cigarettes increased with level of 

performance in school: from 30 percent for those who performed less than 

average to 66 percent for those who performed much better than average 

(Figure 6). 

Brand Switching Brand switching is one measure of the perceived health risk 

associated with lower tar yield cigarettes. The 1986 AUTS asked the following ‘ question of current smokers: “Thinking of your entire smoking history, 

have you ever switched from one cigarette to another, just to reduce the 

amount of tar and nicotine?” Former smokers were asked, “Did you ever 

switch from one type of cigarette to another just to reduce the amount 

of tar and nicotine?” Approximately 38 percent of current smokers and 

26 percent of former smokers answered “Yes.” 

The 1987 NHIS asked current smokers, “Have you ever switched to a low 

tar and nicotine cigarette just to reduce your health risk?” About 44 percent 

of current smokers answered that they had switched for that reason. As 

45 
Smoking and Tobacco Control Monograph No. 7 

Figure 6 

Prevalence (by percent) of use of light and ultralight cigarettes among current smokers,a 

by race/ethnicity and school performance: Ages 10 to 22 years, United States, 1993 

I Ultralights Lights I 

4 66.4 

60- 60.3 

52.6 

46.2 c,

c 

40-

Q)

n 29.7 

20-

n- - White Black Hispanic e Average Average > Average >> Average 

Race/Ethnicity School Performance 

a Who usually buy their own cigarettes. 

Source: Centers for Disease Control and Prevention, 7993. 

shown in Figures 7 and 8, there are clear trends and differences by sex, age, 

race/ethnicity, and education. Figure 7 shows that females (48.4 percent) 

were more likely to switch than males (39.4 percent). Smokers in the 25-to44 and 45-to-64 age groups were most likely to have switched to lower yield 

brands (45.2 and 45.9 percent, respectively), followed by smokers older 

than age 64 (41.3 percent) and those 18 to 24 years (36.4 percent). Figure 8 

shows that whites (47 percent) were more likely to switch than Hispanics 

(30.9percent) or African-Americans (30.8 percent), and the more educated 

were more likely to switch than the less educated. 

Smokers of low-tar yield varieties were more likely to have switched. 

That is, among smokers consuming brands yielding 6 mg or less tar, 

74 percent of current smokers in the 1986 AUTS had ever switched compared 

with 19 percent of smokers consuming cigarettes yielding 16 mg or more 

tar. These patterns were similar for both former smokers (as reported by 

the AUTS) and current smokers (as reported by the "IS). 

Persons who switched brands were more likely to smoke low-tar yield 

brands. For example, according to the 1986 AUTS, 22 percent of switchers 

smoked brands yielding 6 mg or less tar compared with 5 percent of people 

46 
Chapter 4 

Figure 7 

Percentageof current smokers who have ever switched brands,” by sex and age: 

Ages 18 and older, United States, 1987 

6o F 

50 

39.4 

20 

10 

Male Female 18-24 25-44 45-64 65+ 

Sex Age (years) 

* To lower tar/nicotine brands to reduce their health risks. 

Source: National Center for Health Statistics, 1987. 

who had never switched. This suggests that many smokers switch to lower 

tar brands rather than starting with those brands. 

HEALTH BELIEFS Survey data on health beliefs shed light on possible factors that 

AND SWITCHING may drive or influence smokers’ switching to lower tar cigarette 

brands. The surveys indicate that current smokers of lower tar brands and 

persons who had switched brands were more likely to acknowledge health 

risks than those who smoked higher tar brands or who had not switched 

brands. Figures 9 and 10 illustrate this relationship between tar yield of the 

smoker’s brand and beliefs that smoking is related to cancer and emphysema. 

It is worth pointing out that the majority of smokers of high-tar 

cigarettes, as well as smokers who have never switched, acknowledged the 

health risks of smoking (Figure 10). However, there is an inverse gradient 

for both variables. 

Similarly, concerns about health risks decrease as tar yields rise (Table 1). 

Among smokers who switched brands, 85 percent stated that they were 

47 
Smoking and Tobacco Control Monograph No. 7 

Figure 8 

Percentage of current smokers who have ever switched brands: by race/ethnicity and 

education: Ages 18 and older, United States, 1987 

6o r 

47.0 

30.8 30.9 

White Black Hispanic 0-8 9-11 12 13-15 16t 

Race/Ethnicity Education (years completed) 

a To lower tarhicothe brands to reduce their health risks. 

Source: National Center for Health Statistics. 1987. 

concerned about the health effects of smoking compared with 70 percent of 

those who had never switched. Furthermore, people in the lower tar yield 

categories and those who switched were more likely to respond that their 

health had been affected by their smoking, and they were more likely to 

report that a doctor had advised them to quit. 

Moreover, people who smoke low-tar cigarettes and those who switched 

were more likely to acknowledge that some brands are more hazardous than 

others (Table 1). Smokers of low-tar brands were more likely to state that 

their brand is less hazardous compared with smokers of higher tar brands. 

Among switchers, 33 percent believed that their brand is less hazardous than 

other brands. For smokers who had never switched, only 16 percent held 

this belief. 

In the 1993 TAPS, adolescents and young adults who smoked light and 

ultralight cigarettes were asked why they smoked those brands. Four reasons 

were most commonly cited: Thirty-three percent of respondents said that 

48 
Chapter 4 

Figure 9 

Percentage of current smokers who believe that low-tar cigarettes pose reduced cancer risk, 

by tar yield and history of switching: Ages 18 and older, United States, 1987 

50 r 

-

40 - 39.2 

- 32.2 

- 30 

-

- 20 

-

- 10 

-

0 -

56mg 7-15 mg s16mg Ever Never 

Tar Yield (mg) History of Switching 

Source: National Center for Health Statistics. 7987. 

they smoked light or ultralight cigarettes because they taste better, 29 percent 

said they are less irritating, 21 percent said they thought these cigarettes 

were healthier than other brands, and 19 percent said they “just liked them.” 

QUITTING SMOKING The surveys revealed some interesting trends with regard to 

quitting. In the 1987 “IS, participants were asked to identify techniques 

they had used in their efforts to quit smoking. Among participants who had 

switched brands, 38 percent said they had ever switched to lower tar and 

nicotine cigarette brands as a quitting strategy; 62 percent switched for other 

reasons (Table 2). Switchers were more likely to have tried these quitting 

strategies, with the exception of quitting cold turkey, than smokers who had 

never switched. This suggests that switchers were seeking help with quitting. 

In addition, those who smoked lower tar cigarettes were slightly more likely 

to have sought help during previous quit attempts than were persons who 

smoked higher tar cigarettes. 

However, the data from the 1986 AUTS indicate that the prevalence of 

cessation increases with increasing tar yield (Figure 11). That is, ever-smokers 

who smoked higher tar yield brands were more likely to have quit than 

people who smoked lower tar brands. Respondents who had never switched 

were more likely to have quit smoking than switchers. 

49 
Smoking and Tobacco Control Monograph No. 7 

Figure 10 

Percentage of current smokers who believe that cigarette smoking is related to emphysema, 

by tar yield” and history of switchingb: Ages 18 and older, United States, 1987 

84.0 

40 

20 

s6mg 7-15mg z16mg Ever Never 

Tar Yield (mg) History of Switching 

a Of current brand. 

* Ever switched to lower tar/nicotine brands to reduce health risks. 

Source: National Center for Health Statisticx, 1987. 

Table 1 

Health concerns and beliefs of current smokers, by tar yield and history of switching, 

by percent: Ages 17 and older, United States, 1986 

History of 

Tar Yield (mg) Switching 

-<6 7-15 216 Ever Never 

Concerned About Health Effects 84 79 68 85 70 

Some Brands More Hazardous Than Others 60 46 39 54 40 

Their Brand Is Less Hazardous Than Others 48 26 12 33 16 

* Ever switched to reduce tar and nicotine. 

Source: Centers for Disease Control, 1986. 

50 
Chapter 4 

Table 2 

Quit strategies ever used by current smokers, by tar yield and history of switching", by percent: 

Ages 18 and older, United States, 1987 

History of 

Tar Yield (mg) Switching 

-<6 7-15 ->16 Ever Never 

Switch to Low Tar 37 22 18 38 6 

Special Filters 14 9 8 13 4 

Gradual Reduction 39 34 36 42 27 

Nicotine Gum 16 10 10 12 8 

The Great American Smokeout 10 9 8 12 6 

Cold Turkey 86 84 82 82 85 

BooWPamphlet 9 9 7 10 5 

RelativedFriends 18 18 18 20 13 

a Switching to lower tar and nicotine brand to reduce health risks. 

Source: National Center for Health Statistics, 1987. 

Among persons who had ever been regular smokers, those who smoked 

low-tar cigarettes and those who switched to lower tar brands were more 

likely to have made a recent effort to quit smoking and relapsed and were 

less likely to be former smokers (data not shown). Among smokers who had 

never tried to quit, smokers of low-tar cigarettes and those who switched to 

low-tar cigarettes were more likely to have considered quitting (data not 

shown). 

DISCUSSION These data seem to reflect an interplay of the forces of motivation to 

quit and nicotine dependence (Russell, 1981). Smokers of lower tar cigarettes 

appear to be especially interested in quitting and are more actively seeking 

help than smokers of higher tar cigarettes. Perhaps when lower tar smokers 

were unsuccessful in their attempts to quit, they switched to a lower tar brand 

to allay their fears about the health consequences of continuing to smoke. 

The tacit health claims associated with advertisements of the lower tar brands 

may have allayed smokers' health concerns (Davis, 1987). Because of the 

cross-sectional nature of the data, however, further research on the topic is 

warranted. 

Not all switching is a step toward quitting. Three of every five smokers 

who had ever switched to lower tar and nicotine brands did not do so as a 

quitting strategy. Both low-tar cigarette smokers and ever-switchers were 

more likely, compared respectively with high-tar smokers and persons who 

had never switched brands, to (1)acknowledge the dangers of smoking, 

51 
- - 

Smoking and Tobacco Control Monograph No. 7 

Figure 11 

Prevalenceof cessation among ever-smokers, by tar yield and history of switching": 

Ages 17 and older, United States, 1986 

58.1 

50.5 

42.1 

r 

56mg 7-15mg 216mg Ever Never 

Tar Yield (mg) History of Switching 

a Ever switched to reduce tar/nicotine. 

Source: Centers for Disease Control. 1986. 

(2) say that their health has been affected, (3) be concerned about health 

effects, and (4) believe that their cigarettes are safer. 

The data on prevalence of cessation are especially intriguing, given 

that low-tar cigarette smokers and ever-switchers are better educated and 

it is known that persons with more years of education are less likely to be 

smokers and more likely to have quit (Centers for Disease Control and 

Prevention, 1994a; Giovino et al., 1994). These data and the Pollay (1990) 

observation that the tobacco industry seems to'be targeting lower tar yield 

cigarettes toward more highly educated smokers deserve consideration. The 

innovation of quitting smoking, which started among persons with more 

education, may have been replaced by the innovation of switching to lower 

tar brands (Rogers, 1983; U.S. Department of Health and Human Services, 

1989). 

52 
Chapter 4 

As stated by Samet (this volume), available evidence indicates that 

smoking lower tar cigarettes only minimally reduces smokers’ health risks. 

The reduced prevalence of cessation among smokers who have switched 

brands and smokers of low-yield cigarettes, coupled with beliefs among some 

in the public that these cigarettes are safer, suggest that low-yield cigarettes 

have kept many smokers smoking who otherwise might have quit. The net 

effect of the introduction and mass marketing of these brands, then, may 

have been and may continue to be an increased number of smokingattributable deaths. 

QUESTION-AND-ANSWJiRSESSION 

DR. SHIFFMAN: I don’t know if you have these data, but I am wondering, 

when smokers in these surveys make a deliberate switch, do you have a sense 

of how big a jump they make in the FTC tar and nicotine values? 

DR. GIOVINO: We have begun to look at the issue of the penultimate brand 

vs. the current or the last brand. The reason I can’t give you a direct answer 

is because we looked at it as a function of whether or not they smoke more 

now or less now. And I will have to check this, but I think it was about 

.2 mg nicotine. 

DR. HOFFMANN: We know now that nicotine is one major reason that 

people smoke or chew tobacco. Therefore, you could have classified your 

groupings according to nicotine, which I would have done, because that is 

why people smoke; it is not for the tar. 

DR. GIOVINO: I think the analysis clearly could be done both ways, and 

I understand your reasoning. The reason that I felt comfortable with tar is 

because it is based on perceptions. A lot of this is based on perceptions of 

health risks. 

My guess is that they are so highly correlated that the analysis would 

find very similar findings, and if the committee would like me to do that, 

we can certainly do that. 

DR. PETITTI: This is a pretty technical question, but your last slide had a 

conclusion that low-tar smokers are less likely to be former smokers and 

switchers are less likely to be former smokers. I presume those are age 

adjusted? 

DR. GIOVINO: We did age-specific analyses. We did not have time to do 

age-adjusted analyses. We used three age categories: 17 to 34 years, 35 to 

64 years, and 65 plus years. For switching, the relationship held in every 

category; for low tar, it held in every category except the 17 to 34 category. 

DR. BENOWITZ: I wonder if you have any information on smoking of the 

really ultralows, like 1mg and below, because there is some evidence that 

the yields from those are really fundamentally different, and I will be talking 

about that later. But do you know anything about the characteristics of 

those smokers? 

53 
Smoking and Tobacco Control Monograph No. 7 

DR. GIOVINO: The numbers in those categories became very small. You 

know, at 6 mg or less, it was 10or 12 percent. At 1mg, the numbers would 

have been. . . . 

DR. BENOWITZ: So, no one is smoking them. 

DR. GIOVINO: Very small numbers, yes. 

DR. FREEMAN: Do you have any guess or reason why young black males 

in particular are smoking so much less today, since it is obviously not a 

function of education. Do you have any sense of why that is happening? 

DR. GIOVINO: What Dr. Freeman is referring to are the trends in the High 

School Senior data, in National Health Interview Survey data among people 

18to-24, in the National Household Survey on Drug Abuse data, the Youth 

Risk Behavior Survey data, the TAPS data, and others, that show that AfricanAmerican youth are much less likely to smoke than white youth. 

I will take 2 minutes, because it is an interesting study. It is not a school 

dropout effect, because when we look at dropouts, white kids who have 

dropped out are much more likely to smoke than African-American kids. 

Also, regardless of race and ethnicity, all kids who drop out are more likely 

to smoke. 

We don’t believe that it is because they have switched to other drugs. 

We have looked at Monitoring the Future data, and it does not look like 

cigarette smoking has been replaced by an increased use of alcohol and 

other drugs. 

There are some data to suggest that differential misclassification may 

explain some of the difference. There was a paper by Karl Bauman in the 

American Journal ofPublic Health that showed that African-American youth 

may be a little more likely to differentially underreport in a household 

survey. Household surveys pose the most serious concerns about 

confidentiality, unless serious steps are taken to protect confidentiality. 

We see lower smoking rates among blacks in school surveys, where 

there is greater privacy. And even in Bauman’s household survey, mean 

validated tobacco use was three times higher in white youth than in AfricanAmerican youth. 

To answer your question in more detail, variables like discretionary 

income, parental education, importance of religion, and how well they do 

in school do not explain it. In other words, the trends seem to be down in 

African-Americans more than white youth in just about all the subcategories 

that we have carved out. 

There are explanations, and some were presented in the 1994 Surgeon 

General’s report: There have been changes in attitudes about smoking, 

and the attitudes held by African-American youth changed in a much more 

health-promoting direction than the attitudes among white youth. There 

54 
Chapter 4 

appears to have been some sort of social climate change, such that cigarette 

smoking does not appear to be as socially acceptable among AfricanAmericans; there are certainly some reports of grassroots involvement at 

the church and other levels. 

There also appears to be a differential concern about the potential 

weight-controlling effects of cigarettes, with African-American youth being 

less obsessed with slimness than white youth. 

It is a very intriguing phenomenon and one that we have examined in 

detail. 

DR. FREEMAN: Is this reflected in the 18-to 24-year-old group? 

DR. GIOVINO: The prevalence trends have definitely translated into the 

18-to 24-year-old age group, and even in the 25 to 29 age group. AfricanAmericans start smoking about a year later in life, but the differences we 

are seeing are not enough, and we are definitely seeing translation into the 

young adult population. 

DR. STITZER One more question on the youth. Your data seem to 

contradict the popular wisdom that youth begin with light cigarettes. 

I wondered if there were any data suggesting that they do play some role 

in initiation or original experimental use? 

DR. GIOVINO: Some of that dogma, if I understand it right, is that it might 

have influenced young girls starting because they were less irritating, and 

that seems to be part of the scenario. Young girls are more likely to have 

used the lights or the ultralights, to the extent that the cross-sectional data 

can tell us exactly. 

I find myself thinking this, and again, this is hypothesis generation: 

You see a lot more ads for regular cigarettes than you do for light cigarettes, 

especially if you think about Marlboros, Camels, Newports, etc. Regardless 

of the reason, it is possible that they start on the regulars, that the thought 

of quitting occurs to them, they have difficulty quitting and the thought is, 

“Well, I have got to do something here, so maybe I will switch.” It is a 

hypothesis. 

DR. KOZLOWSKI: A number of years ago, Fred Silverstein, Scott Feldon, and 

I published a paper in the \ournaZ ofHealth and Social Behavior on the role of 

low-yield cigarettes and the recruitment to smoking, particularly in women, 

we found, in a school sample. 

And you have to think that there were some young women who were 

particularly sensitive to the effects of smoking. Not all were. In other words, 

a small percentage of the market were under great social pressure to take up 

smoking, and the low-yield cigarette, smoked without vent blocking and so 

on, provided a nice trial-sized dose. So, it helped some people, but it was not 

across the board. 

55 
Smoking and Tobacco Control Monograph No. 7 

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Anonymous. Health claims made for filter cigarettes. 

New York StateIoumal ofMedicine 85(7): 317, 1985. 

Anonymous. Vantage is changing a lot of my feelings 

about smoking. Time Magazine, November 7, 1977. 

pp. 86-87. 

Centers for Disease Control and Prevention. Adult 

Use of Tobacco Survey. Public use data tape, 1986. 

Centers for Disease Control and Prevention. Teenage 

Attitudes and Practices Survey. Public use data tape, 

1993. 

Centers for Disease Control and Prevention. Cigarette 

smoking among adults-United States, 1993. 

MMWR. Morbidity and Mortality Weekly Report 43: 

925-930, 1994a. 

Centers for Disease Control and Prevention. Changes 

in cigarette brand preferences of adolescent 

smokers-United States, 1989-1993. MMWR. 

Morbidity and Mortality Weekly Report 43: 577-581, 

1994b. 

Davis, R.M. Current trends in cigarette advertising and 

marketing. New England Iournal ofMedicine 316: 725- 

732,1987. 

Davis, R.M., Healy, P., Hawk, S.A. Information on tar 

and nicotine yields on cigarette packages. American 

Journal ofhblic Health 80: 551-553, 1990. 

Doll, R., Hill, A.B. Smoking and carcinoma of the lung. 

British Medical Journal 2 740-748, 1950. 

Doll, R., Hill, A.B. A study of the aetiology of 

carcinoma of the lung. British Medical Journal2: 

1271-1286, 1952. 

Federal Trade Commission. “Tar, Nicotine and Carbon 

Monoxide of the Smoke of 207 Varieties of Domestic 

Cigarettes. Washington, DC Federal Trade 

Commission, 1985. 

Federal Trade Commission. Federal Trade Commission 

Report to Congress for 1992. Washington, DC: Federal 

Trade Commission, 1994. 

Gallup International Institute. Teen-age Attitudes and 

Behavior Concerning Tobacco. Report of the Focus 

Groups. Princeton, NJ: The George H. Gallup 

International Institute, 1992. 

Gallup Organization, Inc. The Public’s Attitudes Toward 

cigarette Advertising and Cigarette Tax Increase. 

Princeton, NJ: The Gallup Organization, Inc., 1993, 

pp. 22-24. 

Giovino, G.A., Schooley, M.W., Zhu, B.P., Chrismon, 

J.H., Tomar, S.L., Peddicord, J.P., Merritt, R.K., 

Husten, C.G., Eriksen, M.P. Surveillance for selected 

tobacco-use behaviors-United States, 1900-1994. 

MMWR. Morbidity and Mortality Weekly Report 43(3): 

1-43, 1994. 

Harris, J.A. Working Model for Predicting the 

Consumption and Revenue Impacts of Large Increuses in 

the U.S.Federal Cigarette Excise Tax. Working paper 

no. 4803. Cambridge,MA: National Bureau of 

Economic Research, 1994. 

Levin, M.L., Goldstein, H., Gerhardt, P.R. Cancer and 

tobacco smoking: A preliminary report. Journal of 

the American Medical Association 143: 336-338, 1950. 

Miller, R. U.S. cigarette consumption, 1900 to date. In: 

Tobacco Yearbook, W. Harr (Editor). Bowling Green, 

KY: Cockrel Corporation, 1981, p. 53. 

National Center for Health Statistics. National Health 

Interview Survey Cancer Control Supplement. 

Public use data tape, 1987. 

Norr, R. Cancer by the carton. Reader’s Digest 

December: 7-8, 1952. 

Pierce, J.P., Hatziandreu, E.H., Flyer, P., Hull, J., 

Maklan, D., Morganstein, D., Schreiber, G. Report of 

the 1986 Adult Use of Tobacco Survey. OM 90-2004. 

Rockville, MD: U.S. Department of Health and 

Human Services, Public Health Service, Centers for 

Disease Control, Office on Smoking and Health, 

1990. 

Pillsbury, H.C., Bright, C.C., O’Connor, K.J., Irish, 

F.W. Tar and nicotine in cigarette smoke. lournal 

of Oficial Analytical Chemists 52: 458-462, 1969. 

Pollay, R.W. “The Functions and Management of 

Cigarette Advertising.” Unpublished manuscript, 

University of British Columbia, 1990.20 pp. 

Rogers, E.M. (Editor).Diffusion of Innovations. New 

York Free Press, 1983. 

Russell, M.A. Dependence and motivation to stop 

smoking. In: Smoking and Artm.al Disease, R.M. 

Greenhalgh (Editor). Bath, United Kingdom: 

Pitman Medical, 1981, pp. 285-288 

Schoenbom, C.A., Boyd, G. Smoking and Other Tobacco 

Use: United States, 1987. Vital and Health Statistics. 

Series 10 Data From the National Health Interview 

Survey (No. 169). DHHS Publication No. (PHS) 89-

1597. Rockville, MD: U.S. Department of Health 

and Human Services, Public Health Service, Centers 

for Disease Control, National Center for Health 

Statistics, 1989. 

Slade,J. The tobacco epidemic: Lessons from history. 

Journal ofPsychoactive Drugs 21: 281-291, 1989. 

U.S. Department of Agriculture. Tobacco Situation. 

TS 99. Washington, DC: U.S. Department of 

Agriculture, Economic Research Service, 1962. 

U.S. Department of Agriculture. Tobacco Situation and 

Outlook Report. TS 200. Washington, DC: U.S. 

Department of Agriculture, Commodity Economics 

Division, Economic Research Service, 1987. 

U.S. Department of Agriculture. Tobacco Situation and 

Outlook Report. TS 226. Washington, DC: U.S. 

Department of Agriculture, Commodity Economics 

Division, Economic Research Service, 1994. 

U.S. Department of Health and Human Services. The 

Health Consequences of Smoking for Women. A Report 

of the Surgeon General. Rockville, MD: U.S. 

Department of Health and Human Services, Public 

Health Service, Office of the Assistant Secretary for 

Health, Office on Smoking and Health, 1980. 

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U.S. Department of Health and Human Services. The 

Health Consequences of Smoking: Nicotine Addiction. A 

Report of the Surgeon General, 1988. DHHS 

Publication No. (CDC) 88-8406. Rockville, MD: U.S. 

Department of Health and Human Services, Public 

Health Service, Centers for Disease Control, Center 

for Health Promotion and Education, Office on 

Smoking and Health, 1988. 

U.S. Department of Health and Human Services. 

Reducing the Health Consequences of Smoking: 25 

Years of Progress. A Report of the Surgeon General, 

1989. DHHS Publication No. (CDC) 89-8411. 

Rockville, MD: U.S. Department of Health and 

Human Services, Public Health Service, Centers for 

Disease Control, Center for Chronic Disease 

Prevention and Health Promotion, Office on 

Smoking and Health, 1989. 

U.S. Department of Health, Education, and Welfare. 

Smoking and Health: A Report of the Advisory 

Committee to the Surgeon General of the Public Health 

Service. PHS Publication No. 1103. Rockville, MD: 

U.S. Department of Health, Education, and 

Welfare, Public Health Service, 1964. 

Warner, K.E. Tobacco industry response to public 

health concern: A content analysis of cigarette ads. 

Health Education Quarterly 12: 115-127, 1985. 

Wynder, E.L., Graham, E.A. Tobacco smoking as a 

possible etiological factor in bronchogenic 

carcinoma. A study of six hundred and eighty-four 

proved cases. Journalof the American Medical 

Association 143: 329-336, 1950. 

57 
BLANK PAGE 
Cigarette Smoke Components and Disease: 

Cigarette Smoke Is More Thana Triad of Tar, 

Nicotine, and Carbon Monoxide 

Jeffrey E. Harris 

INTRODUCTION Cigarette smoke is a complex mixture of chemicals. Some smoke 

components, such as carbon monoxide (CO), hydrogen cyanide (HCN), and 

nitrogen oxides, are gases. Others, such as formaldehyde, acrolein, benzene, 

and certain N-nitrosamines, are volatile chemicals contained in the liquidvapor portion of the smoke aerosol. Still others, such as nicotine, phenol, 

polyaromatic hydrocarbons (PAHs), and certain tobacco-specific nitrosamines 

(TSNAs), are contained in the submicron-sized solid particles that are 

suspended in cigarette smoke. 

In view of this chemical complexity, cigarette smoke has multiple, 

highly diverse effects on human health. It is not unexpected that multiple 

chemicals in cigarette smoke can contribute to any single adverse health 

effect. 

Thus, HCN may affect the human respiratory system by its toxic effects 

on the cilia that line the respiratory tract. At the same time, HCN may cross 

the placenta and have toxic effects on the growing fetus. In addition, HCN 

also may cause nerve damage in cigarette smokers with optic neuropathy 

(Costagliola et al., 1989). Although the PAHs and TSNAs in the particulate 

phase of cigarette smoke are known carcinogens, catechols and phenols in 

the particulate phase also are considered carcinogens or tumor promoters. 

Benzene and formaldehyde in the liquid-vapor portion of the smoke also 

may be carcinogenic. 

Aside from specific chemical constituents, certain physical-chemical 

properties of smoke may participate in disease processes. Thus, the pH of 

the smoke may affect the site and degree of nicotine absorption as well as the 

smoker’s depth of inhalation. The oxidation-reduction state of the smoke can 

be important because oxidants influence the maturing of cholesterol-laden 

plaques in the coronary arteries and other blood vessels. In short, cigarette 

smoke is far more than a triad of tar, nicotine, and carbon monoxide. This 

fact needs to be considered carefully in any discussion of the adequacy of 

current cigarette testing methods or current cigarette labeling practices. 

MAINSTREAM VS. Both smokers and nonsmokers can incur adverse health 

SIDESTREAM effects from the smoke of burning cigarettes. Smokers inhale 

CIGARETTE SMOKE mostly mainstream (MS) smoke, which is drawn through 

the burning tobacco column and filter tip and exits through the mouthpiece 

of the cigarette. Nonsmokers inhale mostly sidestream (SS) smoke, which is 

59 
Smoking and Tobacco Control Monograph No. 7 

emitted into the surrounding air between puffs from the end of the smoldering cigarette. Sidestream smoke is the major source of environmental tobacco 

smoke (ETS). 

Although SS and MS smoke have qualitatively similar chemical 

compositions, the respective quantities of individual smoke constituents 

can be quite different (US. Department of Health and Human Services, 

1987 and 1989). For example, in studies of nonfilter cigarettes smoked 

by machines, the yield of CO in undiluted SS smoke was 2.5- to 4.7-fold 

that of MS smoke, whereas the corresponding SS/MS ratio for Nnitrosodimethylamine (NDMA), an animal carcinogen, was 0.2 

(U.S. Department of Health and Human Services, 1989). In one compilation 

of toxic and tumorigenic agents in cigarette smoke, the SS/MS ratio ranged 

from 0.03 to 130 (Hoffmann and Hecht, 1990). In another study, the 

concentration of the carcinogen 4-aminobiphenyl in undiluted SS smoke 

was 32-fold that of MS smoke. The SS smoke from so-called reduced-yield 

cigarettes does not necessarily have reduced emissions of toxic and 

carcinogenic chemicals (Adams et al., 1987; Rando et al., 1992). 

Whereas exposure to SS smoke depends on the distance from the 

burning cigarette and conditions of ventilation, the higher concentrations 

of certain toxic and carcinogenic chemicals in SS smoke result in measurable 

levels of these chemicals in nonsmokers exposed to ETS. For example, 

nonsmokers exposed to relatively high concentrations of SS smoke have 

detectable urinary levels of the metabolites of the tobacco-specific 

nitrosamine 4-(methylnitrosamine)-l-(3-pyridil)-l-butanone(NNK) 

(Hecht et al., 1993). Young children exposed to ETS via their smoking 

mothers have detectable levels of PAH-albumin adducts in their blood 

(Crawford et al., 1994). 

Exposures to specific chemical agents in ETS can in turn produce 

pathological effects in humans and in animal models. The CO in SS smoke 

reduces the blood’s ability to deliver oxygen to the heart, an effect that is 

especially important in patients with coronary heart disease (CHD) (Sheps et 

al., 1990). Secondhand cigarette smoke activates blood platelets, which in 

turn play a role in the development of atherosclerotic plaques in CHD 

(Glantz and Parmley, 1995). 

The remainder of this chapter focuses on the chemical components of 

MS smoke and their health effects on cigarette smokers; however, the 

components of SS smoke and their health effects on nonsmokers cannot 

be ignored. 

MAJOR HEALTH The major health effects of cigarette smoke include: 

EFFECTS OF cancer; 

noncancerous lung diseases; 

atherosclerotic diseases of the heart and blood vessels; and 

toxicity to the human reproductive system. 

60 
Chapter 5 

Other health effects of cigarette smoke, such as retardation of healing of 

peptic ulcers and interaction with certain therapeutic drugs, are not 

considered in detail here. 

The epidemiologic evidence on the degree (if any) to which filter-tipped 

and low-tar cigarettes have reduced the risks of smoking-related diseases are 

reviewed by Samet (this volume). 

The psychoactive drug in cigarette smoke is nicotine. Cigarette smoking 

is a highly controlled form of self-administration of this drug. Nicotine use 

is self-reinforcing. Attempts to stop smoking lead to craving, withdrawal 

symptoms, and high rates of relapse (U.S. Department of Health and Human 

Services, 1988; Harris, 1993). The psychoactive effects of nicotine are 

discussed in detail in chapters by Benowitz (this volume) and Henningfield 

and Schuh (this volume). 

CANCER Cigarette smoking causes cancers of the lung, esophagus, larynx, oral 

cavity, bladder, and pancreas in male and female smokers. In fact, cigarette 

smoking is the major cause of lung cancer in the United States, accounting 

for 90 percent of cases in men and 79 percent in women (U.S. Department 

of Health and Human Services, 1989). Smoking is also reported to increase 

the risks of cancers of the kidney, liver, anus, penis, and uterine cervix as 

well as several forms of acute leukemia (Garfinkel and Bofetta, 1990; 

U.S. Department of Health and Human Services, 1982, 1989, and 1990). 

Numerous epidemiological studies covering the experience of millions 

of men and women over many years show that smokers’ risks of developing 

cancer increase with the number of cigarettes smoked daily, the lifetime 

duration of smoking, and early age of starting smoking. Smoking cessation 

gradually reduces cancer risk, although a persistent excess risk has been 

observed even two decades after cessation (U.S. Department of Health and 

Human Services, 1989 and 1990). Cigarette smoke interacts with other 

causative agents, including alcohol, asbestos, radon daughters, certain viruses, 

and certain workplace exposures, in the development of human cancers 

(U.S. Department of Health and Human Services, 1982, 1989, and 1990). 

Condensates collected from cigarette smoke cause mutations and damage 

to DNA (deoxyribonucleic acid) in laboratory assays of mutagenesis (Gairola, 

1982) as well as malignant transformation (in laboratory tests) of a chemical’s 

ability to induce malignant changes in mammalian cells. The most widely 

used experimental system is the mouse skin bioassay, in which cancers are 

induced by the repeated application of condensates of cigarette smoke to 

the shaved skins of mice. 

Humans naturally puff on cigarettes. The puffed smoke, in a volume 

of about 30 to 70 mL, is temporarily retained in the smoker’s mouth, after 

which it may be inhaled deeply into the lungs. By contrast, some laboratory 

animals breath by panting, and others are obligate nose breathers. Even with 

installation of smoke through artificial airways, it can be quite difficult to 

get the animals to inhale deeply, as human smokers do. Accordingly, the 

61 
Smoking and Tobacco Control Monograph No. 7 

distribution and retention of smoke components in the respiratory systems 

of laboratory animals may not mimic natural human smoking. Nevertheless, 

long-term smoke inhalation regularly induces tumors of the larynx in Syrian 

golden hamsters. Direct installation of cigarette tar into the airways of 

laboratory animals causes lung cancers (Hoffmann and Hecht, 1990; 

U.S. Department of Health and Human Services, 1982). 

MS cigarette smoke contains more than three dozen distinct chemical 

species considered to be tumorigenic in humans or animals (Hoffmann and 

Hecht, 1990; U.S. Department of Health and Human Services, 1982 and 

1989). Among the most prominent are PAHs such as benzo(a)pyrene (BaP); 

aka-arenes such as dibenzo-acridine; N-nitrosamines such as NDMA; aromatic 

amines such as 4-aminobiphenyl; aldehydes such as formaldehyde; other 

organics such as benzene; and certain inorganic compounds such as arsenic, 

nickel, and chromium. Some of these chemicals alone are capable of 

initiating tumors in laboratory animals; others can promote the development 

of previously initiated cancers. Still others indicate direct human 

epidemiological evidence of carcinogenicity. 

Certain chemical components of smoke may contribute to specific 

cancers. For example, TSNAs may contribute to cancers of the lung, larynx, 

esophagus, and pancreas, whereas 4-aminobiphenyl and certain aryl amines 

may contribute to cancer of the bladder (Vineis, 1991). Benzene in cigarette 

smoke may play a role in smoking-induced leukemia (Melikian et al., 1993). 

NONCANCEROUS Cigarette smoking is the main cause of chronic obstructive lung 

LUNG DISEASES disease (COLD), also called chronic obstructive pulmonary disease 

(U.S. Department of Health and Human Services, 1984a). Smoking accounts 

for 84 percent of COLD deaths in men and 79 percent in women (US. 

Department of Health and Human Services, 1989). 

COLD is a slowly progressive illness that develops after repeated insults 

to the lung over many years. In the early years after starting to smoke, an 

individual may report no symptoms. However, even at this early stage 

breathing tests can often detect abnormalities in the small terminal airways 

of the lung (Beck et al., 1981; Seely et al., 1971; U.S. Department of Health 

and Human Services, 1984a), and these abnormalities have been directly 

observed in autopsy studies of young smokers who died suddenly 

(Niewoehner et al., 1974). For smokers in their twenties, there is already a 

dose-response relationship between the extent of abnormal lung tests and 

the number of cigarettes smoked daily. In random population surveys, from 

17 to 60 percent of adult smokers younger than age 55 have detectable small 

airway dysfunction (U.S. Department of Health and Human Services, 1984a). 

Over the course of an individual’s two decades or more of smoking, a 

constellation of chronic respiratory changes develops. These chronic lung 

injuries include (1) mucus hypersecretion with chronic cough and phlegm; 

(2) airway thickening and narrowing, resulting in obstruction to airflow 

during expiration; and (3) emphysema, that is, abnormal dilation of the air 

spaces at the end of the respiratory tree, with destruction of the walls lining 

62 
Chapter 5 

the air sacs, resulting in further airflow obstruction. These changes can 

cause significant respiratory impairment, disability, and death. Although 

individual patients vary in the relative contribution of these three changes, 

those with clinically severe COLD typically have all three. 

Although a minority of cigarette smokers will develop clinically 

severe COLD, some chronic deterioration in lung structure or function is 

demonstrable in most long-term smokers (U.S. Department of Health and 

Human Services, 1984a). Some smokers show more chronic cough and 

phlegm, others more airway obstruction. In general, breathing function 

declines with the increase in a person’s cumulative exposure to smoke, 

measured in pack-years (Dockery et al., 1988). 

Cigarette smoke produces pathological changes in the lungs of smokers 

by a number of different mechanisms (U.S. Department of Health and 

Human Services, 1990). Cigarette smoke is toxic to the cilia that line the 

central breathing passages. These cilia, in combination with mucus 

secretions, defend against deep inhalation of foreign material (U.S. 

Department of Health and Human Services, 1984a). Smoking also induces 

many abnormalities in the inflammatory and immune systems within the 

lung (U.S. Department of Health and Human Services, 1985). In particular, 

cigarette smoke causes inflammatory cells to produce an enzyme called 

elastase, which in turn breaks down elastin, an important protein that lines 

the elastic walls of the air sacs (Fera et al. 1986; U.S. Department of Health 

and Human Services, 1984a). Moreover, oxidants present in cigarette smoke 

can inactivate a separate protective enzyme called alpha,-antitrypsin, which 

inhibits the destructive action of elastase Uanoff, 1985; U.S. Department of 

Health and Human Services, 1984a). 

Many organic and inorganic chemicals in the gaseous, volatile, and 

particulate phases of cigarette smoke appear to contribute to smoke’s 

toxicity to the respiratory system, including hydrocarbons, aldehydes, 

ketones, organic acids, phenols, cyanides, acrolein, and nitrogen oxides. 

Some components contribute to the development of chronic mucus 

hypersecretion in the central airways, whereas others play a greater role 

in the production of small airway abnormalities and emphysematous injury 

to the peripheral air sacs. Oxidizing agents in smoke inhibit the enzymes 

that defend against the destruction of lung elastin (U.S. Department of 

Health and Human Services, 1984a). 

ATHEROSCLEROTIC Cigarette smoking is a major contributing cause to CHD, stroke, 

CARDIOVASCULAR and other atherosclerotic diseases of the circulatory system (U.S. 

DISEASES Department of Health and Human Services, 1984b and 1989). 

Atherosclerosis is a chronic disease that can affect the arterial blood 

vessels in virtually every part of the human body. The most important 

form of atherosclerosis in the United States is coronary atherosclerosis. 

Its manifestations, which include angina, heart attack, heart failure, and 

sudden death, are described by the inclusive term coronary heart disease. 

Atherosclerosis involving the arteries supplying the brain is a form of 

63 
Smoking and Tobacco ControI Monograph No. 7 

cerebrovascular disease. Atherosclerosis involving the arteries to the limbs is 

called peripheral vascular disease (PVD). 

In numerous epidemiologic studies of millions of people, cigarette 

smokers have been found to have higher rates of heart attack, sudden death, 

and other manifestations of CHD. They also have higher rates of stroke, PVD, 

and other atherosclerotic lesions (U.S. Department of Health and Human 

Services, 1984b and 1989; U.S. Department of Health, Education, and Welfare, 

1979). In the Cancer Prevention Study I1 (CPS-11) of more than 1million 

people followed from 1982 through 1986, men currently smoking had a 

94-percent greater risk of CHD than lifelong nonsmokers, whereas women 

currently smoking had a 78-percent greater risk. In smokers younger than 

age 65, men had a 181-percent greater risk and women a 200-percent greater 

risk (U.S. Department of Health and Human Services, 1989). 

Cigarette smoking is sometimes called an independent risk factor for 

CHD because smokers’ CHD rates are found to be higher even when other 

risk factors such as gender, blood pressure, and cholesterol level are taken into 

account. It is sometimes called a modifiable risk factor because one can 

reduce or stop smoking. Although smoking obviously cannot be a cause of 

CHD in someone who never smoked, it can be an important contributor to 

CHD in a smoker. Among 548,000 deaths from CHD in the United States in 

1985, an estimated 115,000 would not have occurred but for the presence of 

cigarette smoking (U.S. Department of Health and Human Services, 1989). 

Cigarette smoke appears to enhance the atherosclerotic process by several 

different mechanisms (U.S. Department of Health and Human Services, 1990; 

Glantz and Parmley, 1995). Cigarette smoking affects cholesterol metabolism. 

Smokers repeatedly have been observed to have lower levels of the protective 

high-density lipoprotein (HDL) cholesterol (Willett et al., 1983), and smoking 

cessation raises HDL cholesterol (Rabkin, 1984). In animal models, cigarette 

smoke can damage the inner lining of blood vessels, thus enhancing the 

transfer of low-density lipoprotein (LDL) cholesterol particles across the 

arterial wall and into the developing cholesterol-laden plaque (Krupski et al., 

1987; Zimmerman and McGeachie, 1987; Penn et al., 1994). Cigarette 

smoking also can affect the blood clotting system, including the adherence 

of blood platelets to the lining of arterial blood vessels (Pittilo et al., 1984; 

U.S. Department of Health and Human Services, 1984b; Burghuber et al., 

1986) and the formation of blood clots that block a narrowed artery. Acrolein 

in cigarette smoke may be partly responsible for its platelet-adhering effects 

(Selley et al., 1990). Cigarette smoke also can cause spasm of the coronary 

arteries. 

Many chemical components of cigarette smoke have been implicated in 

the development of atherosclerotic disease. Nicotine, the major psychoactive 

component of smoke, causes powerful changes in heart rate and blood 

circulation. Nicotine appears to cause injury to the arterial lining (Krupski et 

al., 1987). Carbon monoxide in cigarette smoke binds to the hemoglobin in 

red blood cells, thereby reducing the oxygen-carrying capacity of the blood 

(Sheps et al., 1990). PAHs, such as 7,12-dimethylbenz(a,h)anthraceneand 

64 
Chapter 5 

BaP, have been found to accelerate the development of atherosclerosis in 

animal models; this suggests that cell injury and cell proliferation (or 

hyperplasia) may contribute to the development of the growing plaque 

(Glantz and Parmley, 1991). Hydrogen cyanide, nitrogen oxides, and 

chemical components of cigarette tar also have been implicated. Free 

radicals in cigarette smoke, which are highly reactive oxygen products, 

are damaging to the heart muscle cells (Church and Pryor, 1985). 

CIGARETTE SMOKING Cigarette smoking adversely affects sexual and reproductive 

AND HUMAN function in women in a number of different ways. Cigarette 

REPRODUCTION smoking appears to impair female fertility (Baird and Wilcox, 

1985; Daling et al., 1987; Mattison, 1982; US. Department of Health and 

Human Services, 1980). Among the possible mechanisms are direct toxicity 

to eggs, interference with motility in the female reproductive tract, and 

alterations in immunity that predispose female smokers to infections that 

block the Fallopian tubes (Chow et al., 1988). 

Maternal cigarette smoking has serious adverse effects on the outcome 

of pregnancy. These include retarded fetal growth; low birth weight; 

spontaneous abortion; certain complications of pregnancy, labor, and 

delivery, such as bleeding during pregnancy and prolonged premature 

rupture of membranes; and infant death (U.S. Department of Health and 

Human Services, 1980,1989, and 1990; U.S. Department of Health, 

Education, and Welfare, 1979). Direct nicotine toxicity has been suggested 

as a mechanism for spontaneous abortion (U.S. Department of Health and 

Human Services, 1990). Although a smoking-induced reduction in maternal 

weight gain contributes to fetal growth retardation (U.S. Department of 

Health and Human Services, 1980; Werler et al., 1985), the evidence points 

to oxygen starvation of the fetus and placenta as important factors. Carbon 

monoxide in cigarette smoke can cross the placenta and bind to the 

hemoglobin in fetal blood. Smoking causes constriction of the umbilical 

arteries, impairing placental blood flow. Nicotine, which also crosses the 

placenta, can have a number of toxic effects on the fetus (U.S. Department 

of Health and Human Services, 1980). The carcinogen 4-aminobiphenyl 

crosses the placenta in a mother who smokes and adducts with the 

hemoglobin in the fetus’ blood (Coghlin et al., 1991). Cyanide, another 

component of cigarette smoke, also has been implicated. 

Women currently smoking enter nonsurgical menopause about 1to 

2 years earlier than nonsmokers (U.S. Department of Health and Human 

Services, 1990). Heavy smokers experience an even earlier menopause than 

light smokers. This effect has important consequences for women’s health, 

because the rates of osteoporosis and atherosclerotic cardiovascular diseases 

increase after menopause. One proposed mechanism for early menopause is 

that PAHs in smoke are directly toxic to ovarian follicles (Mattison, 1980). 

Cigarette smoking also may affect male reproductive performance. In 

several studies, men who report impotence (i.e., the inability to maintain an 

erection sufficient for intercourse) were more likely to be cigarette smokers. 

This association between smoking and impotence is particularly common 

65 
Smoking and Tobacco Control Monograph No. 7 

among men who have high blood pressure or diabetes and appears to be 

a consequence of increased atherosclerotic disease in the blood vessels 

supplying the genitalia rather than an effect on sexual drive. 

ABSOLUTE RISK Human epidemiology can be used to estimate quantitatively the 

VS. RELATIVE risk of specific diseases to human smokers. For example, in the 

RISK CPS-I1 study of smoking practices and mortality rates among 

1.2 million U.S. adults followed from 1982 through 1986, about 0.8 percent 

of current male smokers ages 65 or older died of lung cancer each year (US. 

Department of Health and Human Services, 1989), whereas the comparable 

annual lung cancer death rate was about 0.04 percent among men ages 65 or 

older who never smoked. These quantitative risk estimates are often termed 

“absolute risks.” That the continuing smokers’ risk of lung cancer was 

twentyfold that of nonsmokers is an expression of “relative risk.” 

Estimating relative risks from analyses of chemical composition of 

different cigarettes is far more complicated. For example, the smoke from 

cigarette A might contain 0.05 mg of BaP, a known carcinogen, whereas 

the smoke from cigarette B might contain 0.02 mg of BaP. To estimate 

human lung cancer risks from these data alone would require a number of 

assumptions relating the dose of BaP to the incidence lung cancer in humans. 

Whereas cigarette A had 2.5-fold as much BaP as cigarette B, it cannot be 

concluded automatically that the relative risk of getting lung cancer for 

those smoking cigarette A is 2.5-fold greater than those smoking cigarette B. 

The relative concentrations of benz(a)anthracene, another carcinogen in the 

PAH group, might be higher or lower. 

Toxicity studies in nonhuman species also can give estimates of 

relative risk, but applying these estimates directly to humans requires 

caution. The fact that the smoke from cigarette C might produce twice as 

many revertants as cigarette D in a particular strain of the Ames salmonella 

assay is an indicator that C contains higher concentrations of certain 

mutagens. Likewise, if cigarette E produced three times as many tumors as 

cigarette F in a mouse skin carcinogenesis assay, we can conclude that 

cigarette E contains higher concentrations of certain carcinogens, including 

tumor initiators and tumor promotors (DuMouchel and Harris, 1983). 

TAR, NICOTINE, Some studies (e&, Adams et al., 1987) suggest that the yields 

CARBON MONOXIDE, of most toxic agents in cigarette smoke are correlated with 

AND OTHER SMOKE their tar, nicotine, and CO deliveries. Still other studies 

CONSTITUENTS show the correlation to be weak at best. Kaiserman and 

Rickert (1992) found a 0.89 correlation between the declared tar level and 

the BaP delivery of 35 brands of Canadian cigarettes. However, for 16-mg 

tar brands, the measured BaP ranged from 15 to 28 ng per cigarette. Fischer 

and colleagues (1991) found no correlation between tar delivery and the 

concentration of certain TSNAs in 170 European cigarettes. 

The lack of a perfect correlation between tar values and specific chemical 

yields is not simply an artifact of measurement error. As Hoffmann and 

colleagues (this volume) report, there are many alternative methods to reduce 

66 
Chapter 5 

cigarette smoke constituents, including various filter designs, changes in 

paper porosity, mixing of tobacco species, and the use of reconstituted 

tobacco sheets and expanded tobacco. However, all these methods do not 

reduce every smoke constituent uniformly. For example, perforated filter 

tips selectively reduce the volatile and gaseous components of cigarette 

smoke, whereas reconstituted tobacco sheets reduce BaP and tar but not 

acrolein or acetaldehyde. Likewise, as reported by Hoffmann and coworkers 

(this volume), the increased burley tobacco content (and with it, the nitrate 

content) of at least one marketed cigarette resulted in an increase in the 

delivery of NNK, a tobacco-specific nitrosamine, over the course of three 

decades. 

In a study of cigarette brands sold in the United Kingdom from 1983 

through 1990, Phillips and Waller (1991, p. 469) concluded that, “with the 

exception of nitrogen monoxide, which is strongly dependent upon the 

type of tobacco, and the delivery of some phenols and PAHs, which may 

be affected to a minor extent by the design of cigarette,” the three routinely 

monitored smoke components (tar, nicotine, and CO) provided “an adequate 

guide” to the yields of the other chemical entities examined. However, as 

the foregoing review of cigarette smoke constituents and disease suggests, 

the exceptions may prove the rule. It would be unscientific to claim that 

the absolute human risk or even the relative risk of a particular brand of 

cigarettes is lower merely because, on average, everything but TSNAs, phenols, 

and PAHs seems to be lower. With phenols and related flavorant compounds 

implicated in smoke-induced chromosomal damage Uansson et al., 1988), 

it would seem that, at minimum, biological testing would be warranted. 

As discussed elsewhere in this volume, the yields of nicotine and carbon 

monoxide are significantly influenced by the smoker’s style or “topography” 

of smoking, including number of puffs, interval between puffs, velocity and 

volume of each puff, depth of draw, length of cigarette smoked, depth of 

inhalation into the lungs, and other factors. It is possible that these 

differences in smoking topography might selectively influence the yields 

of some smoke chemicals more than others. Fischer and colleagues (1989) 

found that TSNA yields depended on the total volume of smoke inhaled 

by the smoker and that total smoke volume was increased for smokers 

of low- and medium-tar cigarettes. Studies of smokers’ exposure to specific 

carcinogenic compounds (e&, by measurement of PAH adducts to DNA) do 

not always show a relationship between exposure and self-reported smoking 

intensity (Santella et al., 1992). 

SMOKE CONSTITUENTS, Henningfield and colleagues (1994) recently proposed 

CIG ARE’ITE-RELATED modified labeling of cigarettes. Their proposed new 

DISEASE, AND MODIFIED new cigarette label included a warning statement; 

LABELING OF CIGARETTES categorization of nicotine yield; nicotine content; tar, 

nicotine, and CO deliveries (average and maximal); harmful additives; and 

information about factors affecting nicotine delivery. The use of a nicotineyield category was intended to replace such marketing terms as “light” and 

“ultralight.” These authors noted, “An additional strategy that could be used 

67 
Smoking and Tobacco Control Monograph No. 7 

to assist consumers in making informed decisions would be to fully 

disclose the tobacco smoke constituents of potential health significance, 

analogous to harmful constituent disclosure of foods” (Henningfield et al., 

1994, pp. 312-313). 

The new nutritional labels mandated by the Food and Drug 

Administration (FDA) on all packaged foods contain information on a 

wide array of vitamins, minerals, cholesterol, total fat, and saturated fat. 

These labels reflect the product’s characteristics. They make no pretense 

that any two individuals will eat breakfast cereal in the same way. Nor 

do they imply that each and every consumer will understand or want to 

understand each and every entry on the label. 

In the same way, the author has designed a “mock” cigarette label 

(Figure 1)to indicate what such an FDA-style label for cigarettes might look 

like. This is a sample and is not intended to reflect any current brand on the 

market. The opening box gives an explanation as well as a warning about 

the ways in which a smoker can obtain higher yields by changing his or her 

style of smoking. Then some “basic cigarette facts” would be included, such 

as length, type of filter, and weight of tobacco. In addition to data on the 

range of yields of tar (total particulates less nicotine) and nicotine, the label 

would show the range of yields of important smoke chemicals. 

The concept of full disclosure of cigarette characteristics is entirely 

consistent with the current Federal Trade Commission (FTC)method. In 

fact, the current FIT measurements of tar, nicotine, and CO are included 

in the proposed mock label. In addition, as we move to an era where both 

short- and long-term biological testing have become commonplace in 

industry, one might imagine a rating system based on the Ames test, skin 

painting, and other studies. Illustrative results for such biological testing 

are included in the mock label. 

One might object that such detailed disclosure of cigarette characteristics 

will confuse the smoker. Such an assertion is unscientific and unfair. To 

publish a label that discloses, for example, the tobacco-specific nitrosamine 

contents of a particular brand of cigarettes is no more confusing or 

complicated than printing a label that discloses the riboflavin and potassium 

yields of a particular brand of breakfast cereal. It would be remarkable 

to discover cereal manufacturers or consumer advocates arguing that the 

vitamin contents or trace metal levels of cereals should be withheld from 

consumers because vitamin E and zinc levels might correlate-at least 

roughly-with dietary fiber contents. 

To a limited degree, researchers have studied consumers’ responses to 

advertised tar and nicotine ratings of cigarettes. But there are no data-at 

least in the public domain-on the possible effects of providing consumers 

with additional cigarette-specific information of the type considered in the 

mock label. 

68 
Chapter 5 

Figure 1 

“Mock” cigarette label 

Our tarhicotine label has changed! The Food and Drug Administration now requires each pack of 

HARRIS Ultrasto display the deliveries of the most important chemicals in your cigarette smoke. Your 

own smoke intake of these chemicals may vary from low to high depending on the size of your puffs, 

the number of puffs per minute, the depth of your draw, and how far you smoke your cigarette down to 

the filter overwrap. For a factsheet about the new cigarette label, write to: New Cigarette Label 

Factsheet, P.O. Box 7551, Brookline, MA 02146. 

Basic Cigarette Facts 

Cigarette Length 

Cigarette Diameter 

Length of Filter Plus Plugwrap 

Total Cigarette Weight 

100 mm 

8mm 

20 mm 

1.20 gm 

Tobacco Weight 

Type of Filter 

Design of Filter 

U.S.-Grown Tobacco 

0.90 gm

Cellulose Acetate 

Perforated 

55% 

Cigarettes Per Pack 20 

Delivery Per Cigarette Low High 

Nicotine 

Carbon Monoxide 

Carcinogenic PAHs 

Tobacco-Specific Nitrosamines 

Hydrogen Cyanide 

Acrolein 

Formaldehyde 

Nitrogen Oxides 

Catechols 

Phenols 

Nickel 

Total Particulates Less Nicotine 

Redox Potential of Smoke 

pH of Whole Smoke 

Biological Test Results ~ 

Ames Salmonella + 

Tracheal Installation ++ 

Mammalian Cell Transformation + 

Syrian Golden Hamster Inhalation 

Mouse Skin Carcinogenesis 

Antielastase Test 

+ 

++ 

++++ 

INGREDIENTS: Domestic flue-cured, Burley, and oriental leaf tobaccos; flavorants (including menthol 

in HARRIS ULTRAGREENS), and humectants, including diethylene glycol. Citric 

acid added to cigarette paper. Residues of maleic hydrazide (a suckercide used in 

tobacco growing) less than 1 part per million. 

WARNING: Keep out of reach of children! 

Key: PAHs = polyarornatic hydrocarbons. 

69 
Smoking and Tobacco Control Monograph No. 7 

In any case, smokers constitute only the demand side of the cigarette 

market. On the supply side are a handful of cigarette manufacturers who, 

so far as is known, go to considerable lengths to determine the detailed 

characteristics of competitors’ products. From time to time, a cigarette 

manufacturer will disclose the level of a particular chemical in a particular 

brand. One classic example is the claim by one manufacturer, in the early 

1960’s, that a particular brand delivered smoke with reduced phenol, an 

announcement that coincided with scientific reports that the phenol in 

cigarette smoke inhibited the cilia lining in the respiratory tract. However, 

without systematic and complete disclosure requirements, such “competition” 

will remain haphazard at best. In 1989 the tar content was listed on only 

14 percent and the nicotine content on only 11 percent of U.S. cigarette 

packages (Davis et al., 1990). 

Enhanced and complete disclosure of cigarette characteristics by a 

standardized label would create a basis for more effective competition among 

manufacturers. If Hoffmann and colleagues’ (this volume) data are 

generalizable, then the growing trend toward use of burley tobaccos in 

American cigarettes might have resulted in increased deliveries of TSNAs, 

even as other smoke constituents have declined. Without specific disclosure 

of tobacco-specific nitrosamines, it is unclear how this deleterious trend 

would be reversed or even detected. As economists know, competition among 

manufacturers over a specific brand characteristic, such as a cigarette’s TSNA 

delivery, does not require that the average smoker-r even most smokersknow what a “nitrosamine” is. 

QUESTION-AND-ANSWERSESSION 

DR. HOFFMANN: We go through stages in all research; so we go through 

stages in tobacco research. The first stage was to identify those agents that, 

in the laboratory animal, cause disease. The second stage we are in now is a 

biomarker stage. This gives us 4-aminobiphenol, bihemoglobin, and tobaccospecific nitrosamines. 

I do think we are now in a better position to judge the relationship between 

smoke components and disease. One should not forget that we have now 

moved past the stage of biomarkers where it is solely the identification of 

agents, and I do think one should not have such a negative outlook. 

DR. HARRIS: Yes. I did not include as possible endpoints by which to 

compare individual cigarettes the possibility that these components may 

be found bound to the hemoglobin and red cells, or circulating proteins, 

or albumen in the blood. It is a fact that certain biomarkers, certain 

hydrocarbons, 4-aminobicarbons, and other compounds, have been now 

found bound to blood proteins or other compounds, not only among those 

who smoke cigarettes, but recently, in the Journal ofthe National Cancer 

Institute, among those who are exposed passively to cigarette smoke. 

Whether those can be used for a comparative analysis of different cigarettes, 

I do not know, But I would, in order at least to be provocative or speculative, 

I 

70 
Chapter 5 

state that we will soon be entering an era when we can make comparisons 

among cigarettes by more than merely standards of chemical constituents. 

DR. KOZLOWSKI: I imagine that the HARRIS ULTRA is an ultralow-tar 

cigarette, and it is perforated. And so, like other current l-mg tar cigarettes, 

it might be 80 or 90 percent perforated, so you get air dilution of between 

80 and 90 percent. I am disappointed that the label, in talking about 

compensatory smoking factors, does not mention the issues of vent blocking 

and staying away from the vents, because in fact, increased puff numbers 

would have a relatively small effect, if this 90-percent dilution factor was 

not eliminated. 

DR. HARRIS: In designing that mock label, I did not attempt to be 

scientifically precise as to absolutely everything one would put in about 

proper directions for use or factors that might affect yield. Actually, your 

yields could vary, and then afterward put in a perforated tip. If you will 

look carefully, it was a 6-mg tar cigarette but with very high nicotine1mg of nicotine. 

One could argue, however, that if one is to continue to publish what 

basically are the FTC data, expanded possibly to include a high or low range, 

or to include other constituents, that there ought to be something about 

directions for appropriate use. 

DR. HEADEN: Dr. Harris, in proposing a possible design for a cigarette label, 

I would like to know your opinion of who you think the audience is for that 

label. Is it the tobacco industry and other regulators who might possibly be 

able to interpret the information that you have? Is it the consumer, who 

might smoke that cigarette, many of whom have lower educational levels, 

or would it be both? 

DR. HARRIS: I think it would have to be considerate of everyone and, 

although it may sound as if I would add the results of additional constituents 

just to satisfy some intellectually rarified audience, I raise the question, why 

do we put such a large array of constituents on our ordinary food supply? 

Some people might argue that we should not insult consumers by assuming 

that they cannot pick and choose, to understand or use meaningfully some 

forms of information rather than others. At this point, unless there is a 

solid confirmation that all those constituents of smoke, or characteristics 

of cigarettes, are simply summarized by the amount of tar, one wonders 

whether the lack of that information is at least deceiving some people. 

That is the best I can do to answer that. 

DR. SONDIK: Dr. Harris, the label is intriguing, and I would not want to 

spend too much time on it, but a couple of points might differentiate it 

from the FDA label, which I happen to believe is one of the major advances 

in nutrition. The FDA label is designed to aid people in developing their 

diets. Their diet consists of all types of food, and the idea is to integrate 

all of these things together, which is the idea behind putting all of these 

different measurements on it, not just a single measurement, such as 

calories, for example, or total fat. 

71 
Smoking and Tobacco Control Monograph No. 7 

The second thing is, that label must have education along with it. And 

that is part of the program in NCI, the Department of Agriculture, the FDA, 

and others who are involved in a very intense education program-to try to 

be sure that the public knows how to interpret a label like this. So, in a 

sense, that label is more complex and aimed at a variety of types of decisions. 

I would think that a label such as you proposed would be aimed at 

perhaps a single decision, which is whether or not this is a useful thing for 

me to do, trading off whatever my immediate gain might be, and pleasure, 

vs. long-term health effects. Is there a way of getting that onto the label? 

DR. HARRIS: I do not know. It also has occurred to me that once more 

dimensions to cigarettes are specifically disclosed, that would be the basis of 

further competition among cigarette manufacturers. So, the manufacturers 

would then be seeing not only whether a cigarette is low or high in tar, 

nicotine, and carbon monoxide, but in other specific components, too. 

That means that while the consumer does not specifically choose among 

high- or low-benzo(a)pyrene cigarettes, the disclosure of such contents 

provides an incentive for manufacturers to try to reduce that component. 

This is the same way that the disclosure of saturated fat contents in certain 

breakfast cereals or other foods, even without consumer knowledge, 

provides an incentive for some manufacturers to try to reduce that content. 

Nevertheless, it provides some incentive on the supply side, not just the 

demand side. 

DR. BENOWITZ: I know that you are not intending to be totally 

comprehensive about your mock insert, or label, and I think it is worthwhile 

keeping in mind the parallel with foods. If you are talking about limiting 

intake, there really are only two contents that we know about that might 

limit intake. One is the amount of the tobacco in the cigarette, which you 

did put down, and the other is the amount of nicotine contained in there, 

which is something that people do not often think about. But the amount 

of nicotine in tobacco limits what a person can get. And the intake of 

nicotine is not necessarily correlated at all with the yield. 

So, I think that when we think about any sort of labeling for content, 

the nicotine content, which is the maximum available dose one could get, 

should really be a part of it. 

DR. HARRIS: I noticed that that was in your original proposal, and I am not 

an expert on the degree to which nicotine content is very limiting for how 

many smokers. I would rather defer that to a later discussion, as to how 

important that is. 

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Krupski, W.C., Olive, G.C., Weber, C.A., Rapp, J.H. 

Comparative effects of hypertension and nicotine 

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Mattison, D.R. Morphology of oocyte and follicle 

destruction by polycyclic aromatic hydrocarbons in 

mice. Toxicology and Applied Pharmacology 53: 249- 

259,1980. 

Mattison, D.R. The effects of smoking on fertility 

from gametogenesis to implantation. Environmental 

Research 28 410-433, 1982. 

Melikian, A.A., Prahalad, A.K., Hoffmann, D. Urinary 

trans, trans-muconic acid as an indicator of 

exposure to benzene in cigarette smokers. Cancer 

Epidemiology, Biomarkers and Prevention 2(1): 47-51, 

1993. 

73 
Smoking and Tobacco Control Monograph No. 7 

Niewoehner, D.E., Kleinerman, J., Rice, D.B. Pathologic 

changes in the peripheral airways of young cigarette 

smokers. New England Journal of Medicine 291: 755- 

758, 1974. 

Penn, A., Chen, L.C., Snyder, C.A. Inhalation of steadystate sidestream smoke from one cigarette promotes 

atherosclerotic plaque development. Circulation 90: 

1363-1367, 1994. 

Phillips, G.F., Waller, R.E. Yields of tar and other smoke 

components from UK cigarettes. Food and Chemical 

Toxicology 29(7): 469-474, 1991. 

Pittilo, R.M., Clarke, J.M., Hams, D., Mackie, I.J., 

Rowles, P.M., Machin, S.J., Woolf, N. Cigarette 

smoking and platelet adhesion. British Journal of 

Haematology 58(4): 627-632, 1984. 

Rabkin, S.W. Effect of cigarette smoking cessation on 

risk factors for coronary atherosclerosis: a control 

clinical trial. Atherosclerosis 53(2): 173-184, 1984. 

Rando, R.J., Menon, P.K., Poovey, H.G., Lehrer, S.B. 

Assessment of multiple markers of environmental 

tobacco smoke (ETS) in controlled, steady-state 

atmospheres in a dynamic test chamber. American 

Industrial Hygiene Association Journal 53(11): 699-704, 

1992. 

Santella, R.M., Grinberg-Funes, R.A., Young, T.L., 

Dickey, C., Singh, V.N., Wang, L.W. Perera, F.P. 

Cigarette smoking related polycyclic aromatic 

hydrocarbon-DNA adducts in peripheral 

mononuclear cells. Carcinogenesis13(11): 2041- 

2045,1992. 

Seely, J.E., Zuskin, E., Bouhys, A. Cigarette smoking: 

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74 
Chapter 5 

U.S. Department of Health, Education, and Welfare. 

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MD: U.S. Department of Health, Education, and 

Welfare, Public Health Service, Office of the Assistant 

Secretary for Health, Office on Smoking and Health, 

1979. 

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ACKNOWLEDGMENT Financial support from the National Cancer Institute is 

acknowledged, but the contents of this manuscript are the author’s sole 

responsibility. 

75 
BLANK PAGE 
ChaDter 6 

The Changing Cigarette and Disease Risk: 

Current Status of the Evidence 

Jonathan M. Samet 

INTRODUCTION Since the early 1950’s when filter tip cigarettes were first widely 

introduced, the cigarette has evolved continually through modifications 

intended to reduce yields of tar and nicotine (U.S. Department of Health and 

Human Services, 1991). Following the introduction of the filter tip cigarette, 

sales-weighted averages of tar and nicotine deliveries show a temporal trend 

of declining yield, which continues to the present (Figure 1). In the face 

of continued modifications of the cigarette and the seemingly associated 

changes in exposure of smokers to cigarette smoke components, questions 

have been raised concerning the implications of the changing cigarette for 

disease risks in smokers. 

Only epidemiologic studies can provide information on modification of 

the risks of smoking as the cigarette has evolved, and only epidemiologic data 

Figure 1 

Tar and nicotine content of U.S. cigarettes, sales-weighted average basis, 1957-1 987 

40 

c

1957-Reconstituted tobacco 

Nicotine 

3 30 1959-Porous paper 

Y 

E

5 

E 20 

IO 

Q) 

-

w

\ 

\ -/ 1971-Ventilation 

1967-Expanded tobacco 

i

3 

-

Q) 

g 10 

0 

1955 1960 1965 1970 1975 1980 1985 1 

Year 

Source: U.S. Department of Health and Human Services, 1989. 

77 
Smoking and Tobacco Control Monograph No. 7 

can measure the risks of cigarettes under the “natural” circumstances of use. 

However, the dynamic nature of the exposure (Figure 1) challenges the 

epidemiologic researcher to classify accurately the pattern of cigarette use 

when changes are made that may not be indexed by tar and nicotine yields 

measured with a smoking machine. 

In considering the health implications of the changing cigarette, 

the concepts of exposure and dose are fundamental. Exposure has been 

defined by the National Research Council (1991) as the amount of material 

potentially available for interaction with a human, that is, material in contact 

with a person at a boundary, whether that boundary be the skin, lung, or the 

alimentary tract. On the other hand, dose is the amount of material that 

enters the organism. Dose may be further classified as the internal dose 

(i.e., the amount of material deposited) or as the biologically effective dose 

(i.e., the amount of material delivered to some biologically relevant site). 

Changes in the cigarette can be interpreted as potentially leading to changes 

in exposure; the health consequences of changing exposure vary with any 

resultant changes in dose of components of cigarette smoke that cause disease. 

The physiological functioning of the lung is also relevant to 

understanding the linkages in changes in the cigarette to changes in 

exposure and dose. The lung is a complex organ with several different 

“compartments,” including the upper airway that extends from the nose 

and mouth to the larynx; the airways of the lung itself, which include the 

trachea, bronchi, and bronchioles; and the parenchyma of the lung, which 

includes the interstitium and the airspaces, or alveoli. The lung behaves as 

a filter that absorbs and deposits gaseous and particulate components of 

smoke throughout its surfaces during the act of smoking. The sites and 

extent of deposition of inhaled mainstream components vary, depending 

on solubility and other characteristics of gas phase components and the 

sizes of the particles. Cigarette smoke is a dynamic mixture in the respiratory 

tract, changing with humidification of the mixture, growth of particles, 

and changing composition as components are selectively removed by the 

filtration process (U.S. Department of Health and Human Services, 1984). 

These physiological considerations imply that there is no simple relationship, 

linear or nonlinear, between reported tar and nicotine yields-a measure 

of exposure-and biologically effective doses of toxic smoke components 

delivered to the sites of injury in the respiratory tract. 

The measures of cigarette smoking used in epidemiologic research on 

smoking and health can be classified as estimating either exposure or dose. 

The most widely used measures, for example, information on cigarette 

smoking (duration of smoking, number of cigarettes smoked per day, and 

type or brand of cigarettes smoked), are exposure measures. Biomarkers that 

can be interpreted as indicators of dose include levels of carboxyhemoglobin, 

nicotine, and cotinine (U.S. Department of Health and Human Services, 

1990). Thus, for epidemiological purposes, researchers use exposure measures, 

typically obtained by questionnaire, and dose measures, based on biomarkers. 

For example, cigarettes smoked per day is an exposure measure, whereas 

78 
Chapter 6 

pack-years (packs smoked per day multiplied by the number of years smoked) 

is a cumulative exposure measure. An estimate of kilograms of tar deposited 

in the lung is an absorbed dose measure; nanograms of benzo(a)pyrene, for 

example, reaching basal cells might be considered a biologically effective dose 

for carcinogenesis. New markers take dose measures to the molecular level 

(Vineis and Caporaso, 1995). 

To assess the consequences of changes in the cigarette, it is necessary to 

have information on how changes in tar and nicotine yield, as assessed by 

the Federal Trade Commission (FTC) method, affect dose measures, extending 

to the molecular level. Any new approach to testing cigarette yields should 

be designed to be informative both as an exposure measure and as an 

indicator of biologically relevant doses of cigarette smoke components. 

EPIDEMIOLOGIC Epidemiologic evidence is available on the effect of the changing 

EVIDENCE ON cigarette on all-cause mortality and on three major categories of 

THE CHANGING disease caused by cigarette smoking: lung and other cancers, 

CIGARETTE AND nonmalignant respiratory diseases, and cardiovascular disease 

DISEASE RISKS (CVD). The Health Consequences of Smoking: The Changing Cigarette. 

A Report ofthe Surgeon General (U.S. Department of Health and 

Overview Human Services, 1981) addressed the changing cigarette, covering 

the relevant toxicologic and epidemiologic evidence. This chapter considers 

key epidemiologic publications since that report but does not provide a 

systematic overview of the many studies on the changing cigarette. 

The principal study designs that have been used to address the health 

consequences of the changing cigarette are the ecological study, a descriptive 

approach conducted at the group level, and cohort and case-control studies, 

analytic approaches conducted at the individual level. Cross-sectional studies 

have proven informative in investigating nonmalignant respiratory diseases. 

The ecological approach is exemplified by a comparison of temporal changes 

in rates of smoking-related diseases with patterns of consumption of various 

types of cigarettes. The American Cancer Society (ACS) studies of large 

groups of volunteer participants are cohort studies; the participants were 

enrolled, information about smoking was obtained on enrollment and . 

periodically thereafter, the population was followed over time, and mortality 

was ascertained. Some of the earliest evidence on smoking and lung cancer 

was obtained in the classic case-control studies conducted by Doll and Hill 

(1950) and Wynder and Graham (1950). In these studies, the smoking habits 

of patients hospitalized with lung cancer were compared with the smoking 

habits of control patients having another disease. 

Evidence from epidemiologic studies has well-known strengths and 

limitations (Rothman, 1986). Epidemiologic research has had a central role 

in characterizing the consequences of the changing cigarette because it 

supplies direct information on the consequences of varying tar and nicotine 

yield products. Thus, the findings inherently consider compensatory 

changes in inhalation patterns or in numbers of cigarettes smoked and 

provide the evidence needed to answer the question of immediate public 

79 
Smoking and Tobacco Control Monograph No. 7 

health relevance: whether disease risk varies with cigarette tar and nicotine 

yield as determined by the FTC method. 

. Exposure misclassification is a potential threat to the validity of studies 

of the changing cigarette. Typically, the exposure of smokers to cigarettes 

of varying tar and nicotine yields is estimated based on information on 

brands and types of cigarettes smoked. However, smokers may not be able 

to provide a fully accurate history of brands used throughout their lifetimes; 

therefore, estimates of tar and nicotine yield are potentially subject to error 

(U.S. Department of Health and Human Services, 1990). The consequences 

of misclassification include biased estimates of the effect of tar and nicotine 

yields and reduction of statistical power. Additional methodological concerns 

include the possibility of selection bias if smokers affected by symptoms 

or disease tend to switch to lower yield products; another concern is 

confounding by other aspects of lifestyle if smokers of lower yield cigarettes 

differ substantially in lifestyle characteristics from those smoking higher yield 

products. However, the research challenge of studying the consequences of 

the changing cigarette is no different from the challenge posed by other 

complex mixtures of inhaled agents, and epidemiologic research has the 

advantage of integrating the effects of the mixture, even though individual 

components may be interacting in ways that are difficult to characterize. 

Lung Cancer The ACS’s Cancer Prevention Study I (CPS-I) provided early evidence 

on the risks of lower tar and nicotine cigarettes (Hammond et al., 1976). 

CPS-I included about 1million volunteers who were followed from 1960 to 

1972. Mortality was examined by three categories of tar intake-high, 

medium, and low. For all causes of mortality and for lung cancer mortality, 

the standardized mortality ratios declined as estimated tar or nicotine intake 

declined (Table 1). The findings were similar for males (Table 1)and for 

females (data not shown). However, comparison with mortality in neversmokers shows that smokers of even the lowest tar and nicotine products 

nonetheless had substantially higher mortality rates. 

Other studies have had similar findings for lung cancer. Wynder and 

colleagues at the American Health Foundation have conducted an ongoing 

case-control study of smoking and lung cancer that provides information on 

cigarette type and lung cancer risk over decades since the 1950’s. Reports 

from this study have consistently shown that smokers of lower tar products, 

indexed in a variety of ways, have reduced lung cancer risk (Wynder et al., 

1970; Wynder and Kabat, 1988). For example, in a recent report based on 

cases from the late 1970’s and early 1980’s, risks were examined separately 

for persons with squamous cell and smalI cell carcinomas of the lung 

(Kreyberg 1) and adenocarcinoma of the lung (Kreyberg 11) (Wynder and 

Kabat, 1988). Smoking was classified as 100 percent filter, 100 percent 

nonfilter, or intermediate, by number of switchers from nonfilter to filter. 

For smokers of filter cigarettes only, risks were approximately 10 to 30 percent 

less than those of smokers of nonfilters only (Table 2). 

80 
Chapter 6 

Table 1 

Standardized mortality ratios for men in Cancer Prevention Study I for total 

mortality, lung cancer, and coronary heart disease (CHD) by tar and nicotine 

intake 

Tar and Nicotine Intake 

Deaths Higha Mediumb LowC 

Total Deaths 

1960-1 966 1 .oo 0.90 0.88 

1967-1 972 1 .oo 0.98 0.81 

Lung Cancer 

1960-1 966 1 .oo 0.96 0.83 

1967-1 972 1 .oo 0.94 0.79 

CHD 

1 960-1966 1 .oo 0.91 0.93 

1967-1 972 1 .oo 1.03 0.82 

a High = 2.0 to 2.7 mg nicotine and 25.8 to 35.7 mg tar. 

* Medium = intermediate. 

Low = 4.2mg nicotine and targenerally 47.6 mg. 

Source: Hammond et a/., 1976. 

Tabte 2 

Adjusted odds ratios and 95-percent confidence intervals for males in the 

American Health Foundation case-control study, by level of filter smoking 

I 

Tumor Type 

Kreyberg I Kreyberg II 

95% 95% 

Odds Confidence Odds Confidence 

Pattern of Smokinq Ratio I nte mal Ratio Interval 

Nonfilter Only 1 - .oo - 1 .oo 

Switchers (1 -9years) 0.83 0.59- 1.17 0.96 0.61 - 1.51 

Switchers (1 O+ years) 0.66 0.49- 0.90 0.79 0.53- 1.1 8 

Filter Only 0.69 0.37 - 1.27 0.87 0.43- 1.54 

Source: Wynder and Kabat, 1988. 

A multicenter case-control study conducted in Europe during the late 

1970’s also provided information on cigarette type and lung cancer risk 

(Lubin et al., 1984). In this study, risk for lung cancer increased progressively 

in both males and females as the proportion of filter use declined from 

100 percent. Findings were similar in a case-control study that was 

conducted in New Mexico from 1980 through 1983, although a linear 

81 
Smoking and Tobacco Control Monograph No. 7 

dose-response relationship between lung cancer risk and the extent of filter 

cigarette smoking was not observed (Pathak et al., 1986). Other recent casecontrol studies have provided comparable results (Wilcox et al., 1988; 

Kaufman et al., 1989). 

Temporal patterns of lung cancer rates also have been interpreted as 

indicating lower lung cancer risks among smokers of lower tar and nicotine 

cigarettes. It has been suggested that the recent decline in lung cancer 

mortality rates among younger males may reflect changes in the cigarette 

(World Health Organization, 1986). This downturn has been observed in 

the United States and other countries (Gilliland and Samet, 1994). 

Nonmalignant Cigarette smoking has diverse effects on the structure and function of 

Respiratory the lung and is a cause of chronic bronchitis and chronic obstructive 

Diseases pulmonary disease (COPD) (U.S. Department of Health and Human 

Services, 1984). The persistent obstruction to airflow in the lung that is the 

hallmark of COPD reflects underlying changes in the small airways of the 

lung and emphysema, which is the permanent destruction of the air spaces 

of the lung. Chronic bronchitis, a condition of chronic sputum production, 

reflects hyperplasia of the lining of the airways of the lung and mucous gland 

proliferation. Compared with nonsmokers, smokers have a greater frequency 

of cough and production of phlegm, manifestations of the inflammation of 

the lung and increased mucus production secondary to smoking, and 

wheezing; smokers also have lower lung function. 

A significant number of adults in the United States have COPD, which 

now causes more than 60,000 deaths annually (U.S. Department of Health 

and Human Services, 1984). The natural history of this disorder has been 

described through longitudinal investigations that have monitored lung 

function over time in smokers and nonsmokers (U.S. Department of Health 

and Human Services, 1984; Sherman et al., 1993). In nonsmokers, lung 

function increases through late adolescence and early adulthood, maintains 

a plateau across the third and fourth decades, and then begins to decline. 

In smokers, the decline begins at a younger age and tends to be steeper. 

The rate of decline increases with the number of cigarettes smoked per day 

but varies widely among smokers. With continued smoking, those with 

more rapid rates of decline eventually deteriorate to a level of lung function 

associated with impairment, and COPD is diagnosed. Although cessation 

earlier in the evolution of the disease is followed by return of the rate of 

decline to that of nonsmokers (U.S. Department of Health and Human 

Services, 1990), smoking cessation at this point in the natural history of 

the disease is not followed by improvement in lung function. 

Findings have been reported that provide insights concerning tar and 

nicotine yields and respiratory symptoms and lung function level. Auerbach 

and colleagues (1979) quantitated smoking-related changes in the lungs of 

men having autopsies at a Veterans Administration hospital in New Jersey. In 

a rigorously investigated series of autopsied lungs, these investigators showed 

that smokers from a period during which cigarettes had comparatively high 

yields of tar and nicotine (1955 to 1960) had more changes in the airways at 

82 
Chapter 6 

various smoking levels compared with smokers from a later period (1970 to 

1977). They interpreted this temporal pattern as indicating that cigarettes 

with lower tar and nicotine yields had less effect on lungs than did higher 

yield cigarettes. 

A number of studies have shown that smokers of lower yield cigarettes 

have comparatively lower rates of respiratory symptoms. Respiratory 

questionnaire data collected in the late 1970’s from approximately 

6,000 Pennsylvania women are illustrative (Schenker et al., 1982). The brand 

of cigarettes currently smoked was determined and used with FTC tar yield 

information to classify the smokers by tar exposure. Tar yield was positively 

associated with cough and phlegm but not with wheezing or shortness of 

breath. For cough and phlegm, there were consistent exposure-response 

relationships with an approximate doubling of symptom frequency from 

the lowest to the highest exposure category (Table 3). The findings of other 

studies are similar. For example, a large study of civil servants in the United 

Kingdom, the Whitehall study, showed that the percentage of smokers 

reporting phlegm increased with tar yield within each stratum of cigarettes 

smoked per day, even the lowest (Higenbottam et al., 1980). 

Table 3 

Absolute and relative risks of chronic cough and chronic phlegm in Pennsylvania 

women by smoking status, cigarettes smoked per day (CPD), and tar yield of 

current brand 

Chronic Cough Chronic Phlegm 

Smoker 

Classification Risk Relative Risk Risk Relative Risk 

Never-Smokers 0.038 1 .oo 0.033 1 .oo 

Ex-Smokers 0.056 1.46 0.052 1.58 

Current Smokers 

1-1 4 CPD 

7 mg tar 0.073 1.92 0.067 2.04 

15 mg tar 0.1 03 2.71 0.085 2.56 

22 mg tar 0.137 3.61 0.103 3.1 2 

15-24CPD 

7 mg tar 0.1 36 3.58 0.155 4.67 

15 mg tar 0.1 85 4.87 0.190 5.74 

22 mg tar 0.240 6.32 0.226 6.82 

25+ CPD 

7 mg tar 0.273 7.1 8 0.234 7.05 

15 mg tar 0.353 9.29 0.281 8.48 

22 mg tar 0.430 11.32 0.327 9.87 

Source: Schenker et a/., 1982. 

83 
Smoking and Tobacco Control Monograph No. 7 

Respiratory morbidity also has been investigated. Followup of outpatient 

visits by enrollees in a Kaiser-Permanente group over 1year showed that there 

was a reduced risk for pneumonia and influenza but not other respiratory 

conditions, associated with use of low-tar and -nicotine products (Petitti and 

Friedman, 1985a). However, in comparison with nonsmokers, smokers using 

low-tar and -nicotine cigarettes had an increased risk for pneumonia, 

influenza, and COPD. 

Not all studies show less disease associated with lower yield cigarettes. 

One recent study from Finland found that symptom levels in young smokers 

who were just initiating smoking did not depend greatly on tar yield (Rimpela 

and Teperi, 1989). In this 6-year followup study, the youths were surveyed 

on several occasions, and the relationship between tar yield and symptom 

onset was determined. There was little evidence of less symptom occurrence 

in the new smokers using low-tar cigarettes in comparison with those 

smoking higher tar cigarettes. Moreover, symptoms were far more frequent 

in the smokers of low-tar cigarettes in comparison with nonsmokers. In a 

randomized trial in the United Kingdom, lower tar cigarettes were not 

associated with either lower symptom frequency or higher level of ventilatory 

function, as assessed by measuring the peak expiratory flow rate (Withey et 

al., 1992a and 1992b). The investigators monitored urinary nicotine 

metabolites and concluded that compensation led to comparable levels 

across the trial period. 

The evidence does not suggest a relationship between tar yield and lung 

function level. For example, in the Whitehall study (Higenbottam et al., 

1980), there was no cross-sectional relationship between tar yield and level 

of the forced expiratory volume in 1second. In the Normative Aging Study 

(Sparrow et al., 1983), a longitudinal study of U.S. veterans, tar yield of the 

usual brand of cigarettes smoked was not associated with decline of forced 

expiratory volume in 1second. 

Cardiovascular Harris (this volume) discusses mechanisms by which cigarette 

Disease smoking causes CVD. Through some of these mechanisms, cigarette 

smoking is anticipated to increase the incidence of new cases (i.e., to cause 

more disease), whereas other mechanisms are anticipated to exacerbate the 

status of those who already had disease (U.S. Department of Health and 

Human Services, 1990). Thus, factors promoting atherogenesis would 

increase incidence, whereas factors such as sympathomimetic stimulation 

by nicotine or impairment of oxygen delivery by carbon monoxide might 

be expected to have more immediate effects and contribute to morbidity 

and mortality among those with coronary artery disease. 

Strong evidence does not exist for either lower incidence or less morbidity 

from coronary heart disease (CHD) among smokers of lower yield cigarettes. 

In the American Cancer Society’s CPS-I study (Hammond et al., 1976), 

smokers of lower tar products did have lower mortality from heart disease 

(Table 1). On the other hand, two case-control studies carried out during 

84 
Chapter 6 

the 1980’s, one involving men (Kaufman et al., 1989) and the other 

involving women (Palmer et al., 1989), did not show evidence of reduced 

risk for smokers smoking lower nicotine products. Both studies included 

persons with a first and nonfatal myocardial infarction. In the 1980-1981 

study of men younger than 54, neither nicotine nor carbon monoxide yields 

of current brand were associated with risk of myocardial infarction (Table 4). 

From 1985 to 1988, a similar case-control study of women as old as 65 with 

nonfatal myocardial infarction also showed no relationship between nicotine 

or carbon monoxide yields of current brand of cigarettes and risk of 

myocardial infarction (Table 5). 

The study of Kaiser-Permanente enrollees also supplied relevant 

information (Petitti and Friedman, 1985b). Hospitalization for a variety 

of cardiovascular outcomes was assessed in relation to type of cigarettes 

smoked, after adjusting for other predictors. Using a multivariate regression 

model, the investigators found relatively small increases in risk for 

hospitalization as tar yield increased. 

Table 4 

Relative adjusted risk of myocardial infarction in men by nicotine and carbon 

monoxide yield of cigarettes smoked 

95% 

Confidence 

Smoker Status Relative Risk Interval 

Never-Smoker 1 .o 2.5 - 6.7 

Current Smoker 

Nicotine yield (mg) 

c 0.8 3.8 2.3 - 6.5 

0.8-0.9 4.1 2.5- 6.7 

1 .o-1.1 3.4 2.2- 5.3 

1.2-1.4 2.4 1.5- 3.8 

2 1.5 3.2 1.9- 5.6 

Carbon monoxide yield (mg) 

c 10 3.5 1.9- 6.6 

10-14 4.4 2.6- 7.5 

15-17 3.2 2.1 - 5.0 

18 2.9 1.8- 4.5 

2 19 3.3 1.8- 6.0 

Source: Kaufman et a/., 1983 

85 
Smoking and Tobacco Control Monograph No. 7 

Table 5 

Relative adjusted risk of myocardial infarction in women by nicotine and carbon 

monoxide yield of cigarettes smoked 

95% 

Confidence 

Smoker Status Relative Risk Interval 

Never-Smoker 1 .o 

Current Smoker 

Nicotine yield (mg) 

< 0.40 4.7 2.8- 8.0 

0.40-0.63 3.3 2.3- 4.8 

0.64-0.75 3.2 2.2- 4.5 

0.75-1.OO 4.7 3.4- 6.5 

1.01 -1.06 3.6 2.6- 5.0 

1.07-1.29 5.1 3.4- 7.5 

21.30 4.2 2.4- 7.2 

Carbon monoxide yield (mg) 

< 4.8 4.9 2.9- 8.2 

4.8-9.1 4.4 2.4- 4.9 

9.2-11.1 3.8 2.7- 5.4 

1 1.2-14.4 3.8 2.7- 5.2 

14.5-15.0 4.1 2.9- 5.7 

15.1-18.0 4.2 2.9- 6.2 

> 18.0 4.8 2.8- 8.1 

Source: Palmer et ai., 1989. 

CONCLUSIONS The Health Consequences of Smoking: The Changing Cigarette: A Report 

of the Surgeon General (U.S. Department of Health and Human Services, 1981) 

offered conclusions on these three major classes of disease. Do these 

conclusions remain tenable in light of more recent evidence? 

With regard to cancer, the report concluded that: 

Today’s filter-tipped, lower ‘tar’ and nicotine cigarettes produce 

lower rates of lung cancer than do their higher ‘tar’ and 

nicotine predecessors. Nonetheless, smokers of lower ‘tar’ and 

nicotine cigarettes have much higher lung cancer incidence and 

mortality than do nonsmokers (U.S. Department of Health and 

Human Services, 1981, p. 18). 

The more recent case-control evidence remains consistent with the first 

component of this. conclusion. 

With regard to COPD, the report concluded that it was unknown 

whether risk was lower for smokers of low-tar and -nicotine cigarettes 

86 
Chapter 6 

compared with risk for smokers of higher tar and nicotine cigarettes. There is 

no consistent evidence that risk for this disease is associated with the tar and 

nicotine yield of the cigarettes smoked. 

For CVD, the 1981 conclusion remains appropriate: . . .the 

overall changes in the composition of cigarettes that have 

occurred during the last 10 to 15 years have not produced a clearly 

demonstrated effect on cardiovascular disease, and some studies 

suggest that a decreased risk of CHD may not have occurred 

(U.S. Department of Health and Human Services, 1981, p. 125). 

Our research needs have changed little from the agenda set out 

in that report 15 years ago. The report called for further surveillance 

of the characteristics of smoke in relation to the type of cigarettes, 

further characterization of compensatory changes in smoking, better 

understanding of doses of tobacco smoke components delivered to the 

lung, and additional epidemiologic research. Ongoing characterization of 

the health consequences of the changing cigarette should be implemented 

and maintained through cohort studies such as CPS-I or case-control 

methods. New biomarkers of exposure and dose should be applied to 

better understand the relationships of FTC tar and nicotine yields with 

biologically effective doses of smoke components. 

QUESTION-AND-ANSWER SESSION 

DR. PETITTI: It actually does amaze me that the conclusions of this report 

are the same as they were in 1981. It also amazes me how little information 

has developed in this field over the past 14 years. 

I wanted you to comment on an issue that was, I think, not particularly 

well addressed in the 1981 report and has troubled me about the 

epidemiological data. It has to do with the tendency to examine the 

risk of lung cancer in strata defined by number of cigarettes smoked per 

day. When you define smoking by number of cigarettes smoked per day, 

you do take into account compensation by inhalation and amount smoked, 

but you don’t take into account any kind of compensation that might 

occur because of a tendency to smoke an increased number of cigarettes 

per day and smoking a lower yield brand. That would suggest that in order 

to take that into account in the epidemiology, you would have to move 

people to a different category of number of cigarettes smoked per day. 

Do you think that epidemiology can address this issue, and how do you 

think that places limitations on the first conclusion related to lung cancer, 

particularly? 

DR. SAMET: It is a good question and I think much of the discussion 

about smokers’ behavior that will follow will get at just how complex the 

physiology is and how difficult it is to make these determinations in the 

laboratory. 

87 
Smoking and Tobacco Control Monograph No. 7 

Then, if you think about trying to develop approaches that might be 

used in epidemiological studies, based around questionnaires to try to 

develop tools that would provide a better measure of dose, which I think 

is what you are calling for, it becomes very difficult. 

You know, using some of our nested approaches, one might begin to use 

biomarkers within studies, within cohort studies, probably particularly, to 

sort this out. But I think you are pointing to a significant limitation of 

approaching this question in large population studies. 

DR. BENOWITZ: The biggest effect was clearly in the lung cancer data, and 

the lung cancers occurred as a result of cigarettes smoked a long time ago. 

Is there any evidence that there is any difference in risk if you looked at 

modern or filtered cigarettes? 

DR. SAMET: Let me see if I can rephrase the question. Are you asking, has 

there been an attempt to assess whether some estimate of tar dose, or tar 

received, is a better predictor of lung cancer risk than simply proportion of 

filter use? 

DR. BENOWITZ: Yes. What I am wondering is, is there any relevance to 

the data when people were mostly smoking nonfiltered cigarettes to today’s 

cigarette market, where they are filtered? Can the whole thing be done just 

by adding a filter? 

DR. SAMET: Probably the right answer to the question is: I do not know. 

But if we think we could begin to use the information from studies of 

smokers of old nonfiltered products, through smokers of newer products, 

to try and define some kind of an exposure-response relationship, then 

I suppose it could be done. But I think that, if we were to do that, it would 

be subject to a great deal of uncertainty. 

DR. HARRIS: I noticed that one of the studies omitted from your review 

was the second American Cancer Study, CPS-11, which followed people from 

1982 to 1986. I am wondering if anyone knows whether that study will be 

analyzed in terms of the yield or type of cigarette and health outcomes. 

DR. SAMET There has already been a paper describing the demographics of 

tobacco use in that study and predictors of tar yield by various demographic 

predictors. I would anticipate seeing such an analysis eventually. 

DR. WOOSLEY: We have already heard this morning how the marketing and 

the promotion of the low-tar and -nicotine cigarettes have been toward the 

more highly educated portion of the population. We have already seen how 

they responded to that by switching. We have already heard how they have 

expressed greater concern for their overall health. 

I have a serious concern. Do you feel the data have adequately addressed 

the possibility that you are looking at a subset of the population who have 

done something else to modify their health risks and, therefore, have looked 

at a selected population with decreased negative outcomes because of these 

88 
Chapter 6 

other factors, and that we really have not seen any influence of the cigarettes 

themselves? 

DR. SAMET: I referred to that set of concerns under the rubric of selection 

bias. That is, people may select themselves to products based on either 

their response to what they were smoking or other characteristics that are 

relevant-an argument in epidemiology called confounding. 

I think you are right; these are concerns. I think, on the other hand, in 

many of the studies there have been attempts to “adjust,” to the extent one 

can, for such differences in the characteristics of those using different types 

of products. As you look across the consistency of the evidence in different 

populations with different approaches to controlling for such factors, and 

different study designs, a consistency emerges, I think at least for lung 

cancer, that would suggest some modest reduction of risk for those using 

the lower delivery products. 

Could there be some element of residual bias in there? I certainly 

could not exclude it. But when we weigh the evidence in an attempt 

to understand those other factors, the socioeconomic indices and other 

measures in different studies would support that conclusion. 

DR. BENOWITZ: I think that is the most important issue that we have to 

address here today. If labeling something low-tar and -nicotine implies 

improved health compared with higher tar and nicotine, I think those 

confounders have the most impact on that decision. 

DR. HOFFMANN: With regard to Dr. Benowitz’ question to me, it is rather 

interesting to see that multiple studies have shown that the increase in 

adenocarcinoma today is much higher than previously, because the nature 

has changed. So, to me, this has something to do with the cigarette. You get 

more adenocarcinoma in the peripheral lung than in former times; it is a 

ratio of 20 to 1squamous cells, and today you have 1to 1. So, I think at 

least the type of lung cancer that appears today has something to do with 

the change in cigarettes. 

DR. SAMET: But certainly the histologic distribution of lung cancers has 

changed and I agree; we would like to know why. 

DR. DEBETHIZY: Your data about the relationship between nicotine and 

cardiovascular disease are curious to me, because most of the data in the 

literature show that people who smoke low-yielding cigarettes actually 

absorb less nicotine. Could you comment on the fact that you do not see 

any dose-response relationship there? 

DR. SAMET: I am not sure how you would like me to comment. I am 

describing the findings of a case-control study that describes how risks of 

nonfatal myocardial infarction varied with the level of nicotine or carbon 

monoxide intake, as estimated by what brand was being smoked at the 

time of the infarct. 

89 
Smoking and Tobacco Control Monograph No. 7 

These are not biomarker data, so there is no inference in these particular 

subjects as to what the level of nicotine or carbon monoxide may have 

been. The question is, again, looking at the yield or brand as an estimate of 

exposure, there was simply no relationship observed in these observational 

studies. 

DR. HUGHES: In most of these studies, the control group is labeled 

nonsmokers. Is that usually never-smokers? 

DR. SAMET: In most of the studies that are labeled nonsmokers, that is 

a never-smoker group. You basically will see two contrasts: vs. neversmokers or, in some of the studies, the contrast has been made between 

sort of the lower exposure group vs. the higher exposure group. 

DR. HUGHES: The reason I asked that is, it seems to me that using controls 

of ex-smokers would be important for two reasons. One, it would be a 

control for the confounds that Dr. Woosley mentioned earlier. Second, 

all your studies have to do with switching cigarettes. None of them has 

to do with the alternative of either quitting or switching to a low-nicotine 

cigarette. Are there data to inform the consumer of the question, how much 

do I want to improve my health by quitting, vs. how much do I improve my 

health by switching to a low-tar cigarette? 

DR. SAMET Certainly, there are abundant data on how risks of diseases vary 

following cessation. I do not want to complicate this, and it was the subject 

of the 1990 Surgeon General’s report. These risks vary in complex ways for 

different diseases, depending on the age at which the smoker stopped 

smoking and the duration of successful abstinence from smoking. 

So, it is somewhat difficult to capture a single number that describes the 

risk in ex-smokers. It has to be done in a far more complex way. But, on 

the other hand, there are data sets, like the American Cancer Society data 

sets, that would allow one to describe how risks change following smoking 

cessation, for example. And it would be possible to derive some quantitative 

contrast between what might happen to smokers of different ages, different 

prior smoking histories, with switching products vs. cessation. 

DR. RICKERT: On your emphysema slide, the one that dealt with the 

changes in lung function, there was a label that said, “never smoked and 

not susceptible to the effects of tobacco smoke.” Do you have any idea 

what proportion of the population of smokers fell into the category “not 

susceptible”? 

DR. SAMET: Such numbers are not readily available. I think most people 

who work in this field would guess that with regard to COPD, perhaps 20 to 

25 percent of continued smokers seemed to fall into this group of rapid lung 

function decline. 

DR. RICKERT: Are there any postulated mechanisms why smokers should 

be in that group? 

90 
Chapter 6 

DR. SAMET: There are many postulated mechanisms, some of which 

Dr. Harris already surveyed. They are essentially mechanisms having to 

do with the balance between factors in the lung that injure it and those 

that protect it, and how that balance may be shifted in individual smokers, 

either by virtue of genetics or aspects of smoking, toward destruction rather 

than susceptibility. It is the subject of a great deal of research. 

DR. HEADEN: The next Surgeon General’s report will be on smoking and 

tobacco use among ethnic minorities. I want to remind the group that some 

smoking patterns among ethnic minorities, particularly African-Americans, 

differ substantially from smoking patterns of whites. For example, AfricanAmericans have extremely low daily rates of smoking, but they smoke very 

high tar and nicotine cigarettes. Thus, it suggests that perhaps we need some 

new data, oversampling for African-Americans and perhaps other ethnic 

groups, particularly males, to find out what the relationships would be for 

these subgroups. 

DR. SAMET: I would certainly agree. 

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576,1984. F.E., Weiss, S.T. Airway responsiveness in young 

black and white women. American Rwiew of 

Respiratory Disease 148(1):98-102, 1993. 

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Sparrow, D., Stefos, T., Bosse, R., Weiss, S.T. The 

relationship of tar content to decline in pulmonary 

function in cigarette smokers. American Revim of 

Respiratory Disease 127(1): 56-58, 1983. 

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Publication No. (PHS) 81-50156. Rockville, MD: 

U.S. Department of Health and Human Services, 

Public Health Service, Centers for Disease Control, 

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U.S. Department of Health and Human Services. The 

Health Consequences of Smoking: Chronic Obstructive 

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U.S. Department of Health and Human Services, 

Public Health Service, Centers for Disease Control, 

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DHHS Publication No. (CDC) 89-8411. Rockville, 

MD: U.S. Department of Health and Human 

Services, Public Health Service, Centers for Disease 

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and Health Promotion, Office on Smoking and 

Health, 1989. 

U.S. Department of Health and Human Services. The 

Health Benefits of Smoking Cessation. A Report of the 

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8416. Rockville, MD: U.S. Department of Health 

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Prevention and Health Promotion, Office on 

Smoking and Health, 1990. 

U.S. Department of Health and Human Services. 

Strategies To Control Tobacco Use In the United States: 

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Vineis, P., Caporaso, N. Tobacco and cancer: 

Epidemiology and the laboratory. Environmental 

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JWilcox, H.B., Schoenberg, J.B., Mason, T.J., Bill, J.S., 

Stemhagen, A. Smoking and lung cancer: Risk as a 

function of cigarette tar content. Preventive Medicine 

17(3): 263-272, 1988. 

Withey, C.H., Papacosta, A.O., Swan, A.V., Fitzsimons, 

B.A., Bumey, P.G., Colley, J.R., Holland, W.W. 

Respiratory effects of lowering tar and nicotine 

levels of cigarettes smoked by young male middle 

tar smokers. I. Design of a randomised controlled 

trial. Iournal of Epidemiology and Community Health 

46(3): 274-280, 1992~1. 

Withey, C.H., Papacosta, A.O., Swan, A.V., Fitzsimons, 

B.A., Ellard, G.A., Bumey, D.G., Colley, J.R., 

Holland, W.W. Respiratory effects of lowering tar 

and nicotine levels of cigarettes smoked by young 

male middle tar smokers. 11. Results of a randomised 

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Community Health 46(3): 281-285, 1992b. 

World Health Organization. Tobacco Smoking. IARC 

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Agency for Research on Cancer, 1986. 

Wynder, E.L., Graham, E.A. Tobacco smoking as a 

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Wynder, E.L., Kabat, G.C. The effect of low-yield 

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1970. 

92 
Chapter 7 

Biomarkers of Cigarette Smoking 

Neal L. Benowitz 

INTRODUCTION This chapter addresses the following question: To what extent do 

smoking-machine-derived tar, nicotine, and carbon monoxide ratings of 

cigarettes predict how much of those substances smokers actually absorb 

into their bodies? 

Two issues need to be clarified. First is the difference between delivery 

and content: What a cigarette delivers to the smoker is not the same as what 

is present in the cigarette tobacco. Second is the issue of compensation vs. 

regulation or titration: Kozlowski and Pillitterri (this volume) focus on 

compensation-the individual’s smoking behavioral response to a change 

in a cigarette brand; this chapter focuses on cigarettes that people have 

self-selected to smoke. Whether behavioral adjustment to nicotine yields 

indicates regulation or titration or compensation is not important. What is 

important is the relationship between what people choose to smoke and 

their intake of various tobacco-derived toxins. 

USE OF The biomarkers most widely used to quantitate exposure to tobacco 

VARIOUS smoke include nicotine, its metabolite cotinine, carbon monoxide, 

BIOMARKERS and with less success, thiocyanate. Recent investigation has focused 

on various hemoglobin and DNA (deoxyribonucleic acid) adducts and 

excretion of nitrosamines in the urine. These latter measures represent 

important future directions, but there are inadequate data in large enough 

populations to make conclusions about the relationship between these 

measures and U.S. Federal Trade Commission (FTC) yields. The use of 

mutagenic activity of the urine is discussed to address the utility of the 

tar-to-nicotine ratio that is computed from the “FTC method” in predicting 

relative human exposure to tar and nicotine. This is an important 

consideration in estimating human risks from different types of cigarettes. 

NICOTINE Nicotine is rapidly absorbed from cigarettes. It enters arterial 

ABSORPTION circulation first, then venous circulation; nicotine levels then fall 

FROM relatively quickly as it is redistributed from the bloodstream to various 

CIGARElTES body tissues. Subsequently, nicotine levels fall off with an elimination 

half-life of about 2 hours (Benowitz, 1988). 

The intake of nicotine from a single cigarette can be approximated by 

measuring the nicotine blood concentration profile after a person smokes 

a single cigarette. The area under the plasma concentration-time curve is 

a reflection of systemic dose. The 24-hour nicotine consumption also can 

be estimated. Volunteer smokers have been studied smoking cigarettes on a 

research ward, where blood levels could be sampled frequently. -Blood levels 

rise with smoking in the morning, more or less plateau through the latter 

part of the day, and then fall overnight (Benowitz and Jacob, 1984a). 

Carbon monoxide levels also build up during the day, plateau, and then 

93 
Smokinn and Tobacco Control Mononraah No. 7 

fall overnight. By sampling blood periodically throughout the day for 

measurement of nicotine levels, it is possible to estimate daily exposure to 

nicotine in human smokers. 

The metabolic disposition of nicotine in humans has been determined 

based on urine-recovery studies plus infusion studies of nicotine and cotinine 

(Figure 1)(Benowitz et al., 1994). On average, about 70 to 80 percent of 

nicotine is converted to cotinine, which is the main proximate metabolite. 

Most studies of nicotine intake from cigarettes producing different yields 

have used cotinine as the marker of nicotine intake. Cotinine is extensively 

metabolized, primarily to trun~-3’-hydroxycotinine.Nicotine, cotinine, 

and hydroxycotinine also are conjugated as glucuronides. In the urine, a 

relatively small amount of cotinine is excreted unchanged compared with 

the total amount generated. However, in general, urine cotinine is well 

correlated with plasma cotinine so that urine cotinine can be used as a 

surrogate for plasma cotinine concentration uarvis et al., 1984). Saliva 

cotinine also is highly correlated with plasma cotinine and has been used 

in the same way. 

Plasma cotinine levels fluctuate somewhat throughout the day. There 

is about a 15-percent change in cotinine levels from morning to night, 

Figure 1 

Quantitative scheme of nicotine metabolism, based on average excretion of metabolites as 

percentage of systemic dose during transdermal nicotine application 

9.8% 4.4% 0.4% 

4.2% 

Jrans-3- 13.0% Cotinine d 33.6% Hydroxycotinine 

Jrans-3‘-

-

Hydroxycotinine 

I

+ 

Glucuronide Cotinine-N-Oxide Norcotinine Hydroxycotinine 

12.6% 2.4% 2.0% 7.4% 

Note: Compounds in ovals indicate excretion in urine, and associated numbers indicate percentage of systemic dose 

of nicotine. 

Source: Benowitz et ab. 1994. 

94 
Chapter 7 

reflecting the approximately 16-hour half-life of cotinine (Benowitz et al., 

1983a). Because of the relatively small circadian variation, cotinine levels 

can be measured at various times of the day, and this value can be used as 

representative of the average daily cotinine level. 

It is possible, by measuring all the metabolites in the urine, to account 

for an average of 90 percent of the nicotine dose (Benowitz et al., 1994). 

An approach to estimating nicotine consumption is to measure all the 

metabolites in the urine and sum them up. At steady state (where the rates 

of intake of drug and generation of metabolism are the same as rates of 

elimination of drug and metabolites), this sum of all metabolites in a 

24-hour urine excretion reflects the amount of nicotine that a person takes 

in each day. 

NICOTINE CONTENT As noted earlier, cigarette content is not the same as cigarette 

OF TOBACCO VS. yield or delivery. Figure 2 shows data from a 1983 study 

FK YIELD (Benowitz et al., 1983b) that investigated the nicotine content 

of tobacco. The nicotine concentration of tobacco averaged 1.6 percent. 

There was no relationship between nicotine content in the whole tobacco 

rod and the FTC-predicted nicotine yield. There was a significant inverse 

relationship between the concentration of nicotine and the FTC nicotine 

yield. Thus, the yield as measured by smoking machine gives no information 

whatsoever about the content of nicotine or other potential toxins in the 

tobacco. The content of nicotine in the tobacco simply represents the 

ultimate limit of the nicotine dose. The FTC method provides no information 

about the amount of nicotine that could be obtained from the tobacco if 

a person smoked it in a way to optimize intake. 

QUANTITATING There are four general methods for quantitating the intake of 

NICOTINE INTAKE nicotine from tobacco: (1)In circadian fashion, measure blood 

IN SMOKERS nicotine levels during cigarette smoking (Benowitz and Jacob, 

1984a and 1984b). If the clearance of nicotine also is measured by 

intravenous infusion of nicotine, blood levels during smoking can be 

converted to an absolute daily dose of nicotine. (2) The same can be done 

with blood level data after a person has smoked one or two cigarettes 

(Benowitz et al., 1991). (3) Blood cotinine levels during ad libitum cigarette 

smoking have been used widely to estimate nicotine intake, which is 

discussed below. (4) Finally, as mentioned by Byrd and colleagues (1995), 

measuring urine nicotine and metabolites during ad libitum smoking can be 

used to estimate nicotine intake. These four ways can be used to address the 

question of how much nicotine is being taken into the body from smoking. 

Table 1presents a summary of data on the dose per cigarette from 

the first three methods. The first method was used to study 44 smokers, 

measuring blood levels during 24 hours of smoking, at steady state (Benowitz 

and Jacob, 1984a, 1984b, and 1985). The dose was estimated to be about 

1mg per cigarette, with a range of 0.37 to 1.60 mg per cigarette. 

95 
Smoking and Tobacco Control Monograph No. 7 

Figure 2 

Nicotine content of cigarettes as compared with FTC-determined values 

(regression analysis) 

E 

.-w

5 

>. 

0 

r = 0.53 

p c 0.05 

a 

Q

C 

0 

0 

z 

.-

c 

.-

3[2 

C

4-

Q 

$ 

n 

A 

vF 

'0

"r 

0.2 

0 

0.4 0.6 0.8 1.0 1.2 

FTC Nicotine Yield (mg) 

1.4 1.6 

r = 0.10 

NS 

.-

: 

w

Q

C 

0, 

.-

.-8

c 

z 

5L) 012 014 016 0:s 110 112 

FTC Nicotine Yield (mg) 

114 l!S 

Note: "Nicotine intake per cigarette (mg)" indicates total amount of nicotine in the length ofcigarette 

tobacco rod smoked in the standard FTC smoking machine assay. 

Key: NS = not significant. 

Source: Benowitz et a/., 1983b. 

The second method is based on studies of persons smoking one or two 

cigarettes (Benowitz et al., 1994). This method produced an average dose of 

2.3 mg per cigarette, with a range of 0.37 to 3.47 mg. The study paradigm 

was one in which smokers were deprived overnight and given only one or 

two cigarettes to smoke in the morning. These were the only cigarettes 

allowed all day. The unusually high dose per cigarette most likely reflected 

96 
Chapter 7 

Table 1 

Summary of absolute bioavailability of nicotine from cigarette smoking studies 

Systemic Dose 

(mghigarette) 

Standard 

Method N Average Deviation Range Reference 

1 22 1.04 0.36 0.37-1.60 Benowitz and Jacob, 1984a 

11 1.oo 0.1 5 0.87-1.48 Benowitz and Jacob, 1984b 

11 0.90 0.1 5 - Benowitz and Jacob, 1985 

2 10 2.29 1.oo 0.37-3.47 Benowitz et al., 1991 

3 20 0.87 0.41 0.22-1.92 Benowitz and Jacob, 1994 

the smokers’ anticipation of no more cigarettes becoming available that day. 

This finding illustrates the tremendous range of nicotine intake a smoker 

has when there is a need, or an anticipated need, for nicotine. The intake 

of nicotine per cigarette in this study was double that typically consumed 

from ad libitum daily smoking. Consistent with this observation was 

another study in which subjects tripled their intake of nicotine per cigarette 

by smoking more intensely when the number of cigarettes allowed to be 

smoked per day was limited (Benowitz et al., 1986a). 

The third method, that is, measuring blood cotinine concentrations, 

resulted in an estimated dose of about 0.9 mg of nicotine per cigarette, with 

a range of 0.22 to 1.92 mg per cigarette (Benowitz and Jacob, 1994). What is 

the quantitative relationship between nicotine intake and yield? Figure 3 

shows nicotine intake data from volunteer smokers studied whose plasma 

nicotine levels were measured while they smoked their usual brand of 

cigarettes ad libitum while in a research ward (Benowitz and Jacob, 1984a). 

There was no correlation between the FTC-measured nicotine yield and 

study-measured intake of nicotine. The only yield that turned out to be 

accurate was 1mg, which is fortuitous because it represents the average 

consumption. Also, most smokers of nonfiltered cigarettes took in less 

nicotine than predicted from the FTC yield. People who smoked low-yield 

cigarettes took in, on average, more nicotine than predicted by ETC yield. 

It is possible that in the 1940’s and 1950’s, when people smoked cigarettes 

with a nominal yield of 2.5 mg or higher of nicotine, they may in fact have 

been undersmoking those cigarettes and taking in considerably less smoke 

per cigarette than they do now. That behavior might explain the change in 

lung cancer pathology over the years. That is, a change in depth of inhaling 

and intensity of smoking may affect the location of the lung tumor. 

97 
Smoking and Tobacco Control Monograph No. 7 

Figure 3 

Regression analysis of relationship between nicotine intake per cigarette and 

machine-determined nicotine yield 

2.0 

r = -0.12 

NS 

Line of identity, 

I 

0 

y= 1.25-0.16~ 0 

0 

0 

0 

WE" 

1.5 a 

a 

a 0 

0 

0 

B

5 

UJ

i3 

i 1.0 

al 

Y 

(P 

C

c,

- 0. 

al

.-C

c, 

.-8 

z 

0.5 

1 

0. 

0 

0 

8 0 

I 0 Nonfilter 1

0

0.5 1 .o 1.5 2.0 

FTC Machine Nicotine Yield (mg) 

Key: solid line = regression line; broken line = line of identiiy, which indicates points at which 

measured nicotine intake per cigarette equals machine-determined nicotine yield; 

NS = not significant. 

Source: Benowitz and Jacob, 1984a. 

COTININE What is the quantitative relationship between cotinine levels and 

LEVELS AND the intake of nicotine from smoking? To address this question, dual 

NICOTINE infusions of deuterium-labeled nicotine and cotinine were given to 

INTAKE smokers (Benowitz and Jacob, 1994). From resultant blood level data, 

it was possible to calculate the percentage of nicotine that is converted to 

cotinine and the clearance of cotinine per se. From these parameters can be 

derived a factor (K) that relates a given blood level of cotinine at steady state 

98 
Chapter 7 

to a given daily intake of nicotine, a factor that averages 0.08. Thus, for a 

typical smoker with a level of 300 ng/mL, nicotine intake is estimated to be 

24 mg per day. Based on average cigarette consumption, that represents an 

intake of about 1mg of nicotine per cigarette. This K factor did not vary as a 

function of whether a person was a smoker or nonsmoker, brands of cigarette 

smoked, or gender. Thus, the author is aware of no bias in using this K factor 

to estimate the dose of nicotine based on a plasma cotinine concentration. 

Data from a study of 136 smokers entering a smoking cessation program 

are shown in Figure 4 (Benowitz et al., 1983b). There was a weak relationship 

between FTC yield and cotinine level. The slope of this relationship was 

shallow and, in this study, not significant. From the lowest to the highest 

yield of cigarettes, there was only a 5- to 10-percent change in cotinine level, 

reflecting a 5-to 10-percent change in nicotine intake. There was a much 

stronger correlation between cigarettes per day and cotinine level (or nicotine 

intake). Thus, the greater the number of cigarettes a person smokes, the more 

nicotine is taken in. This is important because some studies, such as that of 

Rosa and colleagues (1992), purport to show a strong relationship between 

Figure 4 

Afternoon blood cotinine concentrations (Group 1) as compared by regression analysis with the 

number of cigarettes smoked per day (Panel A) and with the FTC-determined nicotine values 

(Panel B) 

1,000 I B n = 136 

1 0 r = 0.15 

NS 800 

400 

) 

200 

0 

0 10 20 30 40 50 60 70 80 90 10 0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0 

Cigarettes per Day FTC Nicotine Yield (mg) 

Note: These smokers’ values were so similar that plots of individual values overlapped. The total number of subjects 

shown in Panel B is lower because data for a few subjects were incomplete. Morning blood cotinine 

concentrations (Group 2, not shown) were on average slightly lower but had similar correlations with the number 

of cigarettes (r = 0.45) and the FTC yield (r = 0.06). 

Key: NS = not significant; 0 = 1 observation;0 = 2 observations; A = 3 observations;0 = 4 observations. 

Source: Benowitz et al., 19836. 

99 
Smoking and Tobacco Control Monograph No. 7 

predicted nicotine intake and cotinine levels. But nicotine intake was 

calculated by Rosa and colleagues as the multiple of cigarettes per day times 

F Kyield. The strength of the relationship between this hybrid parameter 

and ITC yield derives primarily from the cigarettes-per-day term rather than 

from the FTC-yield term. 

Figure 5 presents data by Gori and Lynch (1985)based on a population 

of more than 800 smokers recruited at shopping malls. These were not 

smokers who were trying to stop smoking. Plasma cotinine and nicotine 

concentrations were measured. The average cotinine concentration was 

about 300 ng/mL. Again, there was only a shallow slope in the relationship 

between FTC nicotine and cotinine level, with little difference in cotinine 

level comparing the lowest and the highest FTC nicotine yields. 

Figure 5 

Mean plasma nicotine and cotinine concentrations as a fraction of FTC nicotine 

yield of cigarettes smoked: n = 865 

- 10 

-5 

Key: solid line = mean; broken line = 95-percent confidence intervals. 

Source: Gori and Lynch, 1985. 

100 
Chapter 7 

ULTRALOW-YIELD Yields from the ultralow cigarette may differ from yields from 

CIGARETTES other cigarettes. Figure 6 shows data from another study of 

smokers of cigarettes of different yields compared by category of FTC nicotine 

(Benowitz et al., 1986b). The high-yield category was 1.0mg of nicotine or 

higher; the low was 0.60 to 0.99 mg; the very low was 0.20 to 0.59 mg; and 

the ultralow was less than 0.20 mg nicotine per cigarette by FTC method. 

Figure 6 

Expired carbon monoxide, plasma thiocyanate, blood nicotine, and cotinine 

concentrations in 248 habitual smokers of cigarettes according to FTC yield 

40 

u) 

Q)*

zm 35-

-

b] I 

[I 051 

.F 30 - - 30 

0 

25 - - 25 

Q) 30 - - 30 u CUn 2 0.2 E *ze0 a 25 -0-25 rq4 20 - - 20 

Q) 

- 175 

51 

cg - 150

.P 5 

150 

125 /--- 125 

20 - - 20

.-ET

5E 

00) 15-

zs 

10 -$1:: 

- 350 

.-ET - 300 

.E E 250 - 250 50 

200 200 

0.5 Ij_l 150 !I 150

c 0.20 0.20-0.59 0.60-0.99 2 1.00 

";; 1:: 

101 
Smoking and Tobacco Control Monograph No. 7 

The ultralow cigarettes are typically rated 1mg of tar or less. Smokers of 

ultralow-yield cigarettes smoked on average a few more cigarettes per day 

than other smokers. This appears to be one way in which these smokers are 

compensating for lower nicotine yields. Of note, carbon monoxide levels 

were similar for all yields. Thiocyanate, nicotine, and cotinine levels were the 

same for smokers of cigarettes with nicotine yields of 0.20 mg and higher. 

Only in the ultralow group was there any reduction in nicotine exposure, 

about 30 percent. Thus, cotinine levels produced by smoking ultralow-yield 

cigarettes, instead of averaging 300 ng/mL, averaged about 200 ng/mL. 

Gori and Lynch (1983) presented similar findings in a larger group of smokers. 

Smokers of the low-yield cigarette brand had the same mean cotinine levels 

as smokers of all other cigarette brands. In contrast, smokers of ultralow-yield 

cigarettes had lower cotinine levels, averaging about 200 ng/mL. Note that 

200 ng/mL still corresponds to a daily intake of 16 mg of nicotine per day. 

If the FTC yield of 0.1 mg nicotine per cigarette were correct, one would 

need to smoke 160 cigarettes per day to achieve an intake of 16 mg. These 

smokers were not smoking 160 cigarettes per day. Thus, the FTC information 

on the ultralow-yield cigarette does not provide meaningful quantitative 

information, although there may be a difference between the ultralow- and 

higher yield cigarettes. 

NICOTINE INTAKE Table 2 provides a summary of several studies of nicotine 

AND MACHINE- intake vs. machine-derived yields. These are studies that have 

DETERMINED YIELD examined the relationship between FTC machine yield and 

nicotine intake measured either by cotinine concentrations or by nicotine 

concentration. Rickert and Robinson (1981) reported plasma cotinine 

concentrations vs. machine nicotine yield and found no relationship. 

Russell and coworkers (1980) studied 330 subjects and found a weak 

relationship between plasma nicotine concentration and yield. Benowitz 

and colleagues (1983b) studied 272 smokers interested in smoking cessation 

and found no significant relationship between plasma cotinine and yield. 

Ebert and coworkers (1983) found a shallow relationship between plasma 

nicotine and yield. Gori and Lynch (1985) found a very shallow slope with 

865 subjects but also found significant relationships because of the large 

number of subjects. In a study by Benowitz and colleagues (1986b), cotinine 

concentrations were virtually the same for any cigarette with a yield of 

0.2 mg and more and were a third less for the ultralow cigarettes. In a study 

by Russell and coworkers (1986), the 392 smokers studied showed a shallow 

relationship between cotinine level and nicotine yield. Rosa and colleagues 

(1992) found a shallow slope relating cotinine level vs. FTC yield, similar to 

that of other studies. However, when Rosa and coworkers (1992) combined 

cigarettes per day times FTC yield, they found a strong reiationship, which 

they interpreted as supporting the utility of the machine test method. 

In 298 Hispanics, Coultas and coworkers (1993) showed findings similar 

to those of the other studies. 

The Byrd and colleagues study (1995) was the only study with different 

results: thirty-three volunteers were asked to provide 24-hour urine samples 

in which nicotine and metabolites were measured. The nicotine intake was 

102 
Chapter 7 

Table 2 

Studies of nicotine intake compared with machine nicotine yield 

Nicotine 

Study Population Yields (mg) Results 

Rickert and Robinson, 

1981 

84 during routine medical 

exams 

0.25-1.3 PCOT vs. Mach-N 

r = 0.08 

Russell et ai., 1980 330 from smokers’ clinics 

or research volunteers 

0.5-3.5 PNIC vs. Mach-N 

r = 0.21a 

Benowitz et al., 1983b 272 seeking smoking 

cessation therapy 

<0.1-1.9 

r = 0.15 (n = 137) 

r = 0.06 (n = 123) 

BCOT VS. FfC-N 

Ebert et al., 1983 76-mix of smoking cessation, 

hospital employees, 

ambulatory patients 

0.1-1.5 

r = 0.2!ja 

PNIC VS. FTC-N 

Gori and Lynch, 1985 865 recruited from shopping 

malls; 10 or more cigarettes 

per day 

0.1-1.6 PNlC VS. FTC-N 

r = 0.37a 

r = 0.23a 

PCOT VS. FTC-N 

Benowitz et al., 1986b 248 seeking smoking 

cessation (1 37 from 

previous study) 

0.1 -1.9 BCOT values similar for 

BCOT 2/3 of others for 

FTC-N0.21 to > 1.0 

FTC-N < 0.20 

Russell et al., 1986 392 from smokers’ clinics - BCOT vs. Mach-N 

r = 0.13a 

BNlC vs. Mach-N 

r = 0.26a 

Rosa et al., 1992 125attending military 

medical center 

0.38-1.38 BCOT vs. Mach-N 

r = 0.30 

Coultas et al., 1993 298 from Hispanic 

household survey 

-

r = 0.12 

SCOT VS. FTC-N 

Byrd et al., 1995 33 volunteers 0.13-1.3 Urine N + metabolites 

VS. FTC-N 

N/24 hr: r = 0.68a 

N/cig: r = 0.7ga ~ 

a p < 0.05. 

Key: PCOJ = plasma cotinine concentration; Mach-N = Smoking-machine-determined nicotine yield; PNlC = plasma 

nicotine concentration; BCOT = blood COtinine concentration; FK-N = machine yield by FJC method; 

BNlC = blood nicotine concentration; SCOT = saliva cotinine concentration; N = nicotine. 

103 
Smoking and Tobacco Control Monograph No. 7 

taken on the basis of total recovery. This study found a strong relationship 

between yield and nicotine intake per cigarette per day that was totally 

different from any other study’s findings. There are serious methodological 

concerns that might affect these conclusions. First, there were only 

33 subjects, and recruitment procedures were unclear. In contrast, data 

already presented involving 2,000 individuals have shown a weak or no 

relationship between cotinine and FTC nicotine yields, so there is a problem 

of generalizability of the Byrd data. Second, an examination of particular 

data in the 1-mg tar group results in an average intake of 9 mg nicotine. 

However, the studies of Gori and Lynch (1985) and Benowitz and colleagues 

(1986b) showed an average cotinine concentration of 200 ng/mL for large 

groups of smokers of the same ultralow-yield cigarettes. A cotinine level 

of 200 ng/mL would correspond to an average daily intake of 15 or 16 mg, 

not the 9 mg reported by Byrd and colleagues (1995). Thus, even if only 

one group is studied, the subjects are not representative of the much larger 

numbers of subjects that have been studied by other investigators. 

CARBON Gori and Lynch (1985) have provided data on carbon monoxide levels in 

MONOXIDE a large group of smokers of cigarettes of different yields (Figure 7). Their 

AND FIT study and other studies have found virtually no relationship between 

YIELD carbon monoxide levels and FTC yields, even for the ultralow group. 

Thus, FTC carbon monoxide yield appears to be of no value in predicting 

human carbon monoxide exposure. 

TAR-TO-NICOTINE The tar-to-nicotine ratio also must be considered. Some authors 

RATIO have argued that even if there is only a small reduction of 

nicotine, because the machine tar-to-nicotine ratios are lower for low-yield 

cigarettes, there is a disproportionately greater overall health benefit due 

to reduced tar exposure (Russell kt al., 1986). The question is whether 

machine-determined tar-to-nicotine ratios predict ratios of exposure in 

human smokers. 

The author attempted to examine this question by studying mutagenic 

activity of urine by Ames test. This test involves culturing salmonella bacteria 

that are unable to generate histidine and therefore cannot grow. However, 

if the bacteria are mutated so that they can make histidine, they can grow. 

Growth can be quantitated by the number of colonies on a culture plate, 

and the number of colonies can be used as a measure of mutagenic activity 

of chemicals that were added to the salmonella culture before incubation. 

It is well known that the urine of cigarette smokers is mutagenic, presumably 

reflecting exposure to chemicals found primarily in cigarette smoke tar 

(Yamasaki and Ames, 1977). 

Figure 8 shows urine mutagenicity data from one individual smoking 

his or her own brand of cigarettes who switched to a Camel (1mg nicotine) 

cigarette, then switched to a True (0.4 mg nicotine) cigarette, and followed 

with a period of no smoking (abstinence). Urine mutagenicity was fairly 

stable for the individual, and there was no difference between smoking the 

Camel and True cigarettes. 

104 
Chapter 7 

Figure 7 

Mean expired air carbon monoxide values as a function of FTC carbon monoxide yield of 

cigarettes smoked 

6o r 

I I I I I I I I I 

0 2 4 6 8 10 12 14 16 18 20 

FTC Carbon Monoxide (mg/cigarette) 

Key: solid line = mean; broken line = 95-percent confidence intervals. 

Source: Gori and Lynch, 1985. 

Figure 9 shows data from a crossover study of urine mutagenicity and 

nicotine intake from smokers smoking their own brand, high-yield (Camel), 

and low-yield cigarettes (True) (Benowitz et al., 1986b). The mutagenic 

activity of the urine was lower for both Camel and True compared with 

the usual brand, most likely because smokers did not like these other brands 

of cigarettes as much as they liked their own. However, the mutagenicity 

values for Camel and True were similar. The ratio of mutagenic activity 

over the 24-hour period under the nicotine plasma concentration-time curve 

(the latter being'an estimate of daily nicotine intake) was used as a surrogate 

for tar-to-nicotine ratio and was the same in all conditions, although the 

machine-predicted ratios were 14.8 for smoker's own, 15.1 for Camel, and 

11.5 for True. Thus, the in vivo tar-to-nicotine ratio did not correspond to 

differences in the machine-determined tar-to-nicotine ratios for different 

brands. 

Figure 9 also shows similar data when switching to Carlton, which is an 

ultralow-yield cigarette. There was a small difference in the ratio of mutagenic 

105 
---- 

Smoking and Tobacco Control Monograph No. 7 

Figure 8 

Urinary mutagenicity based on 24-hour urine collections in a habitual smoker 

smoking his or her own brand, Camel (high-yield), and True (low-yield) cigarettes 

n 

Q) 

=I 

.-E 

150 

125 

Own 

-e 

Camel True

4

Abstinence 

J

E

2 100 

z 

a 

v 

g.-

C 

-

0

75 

0 

0 50 

C 

E2 

CI 

25 

DMSO only 

U 

0 a 

0 2 4 6 a 10 12 14 

Days of Study 

Note: Mutagenic activity tends to be constant from day to day and falls to the DMSO control value 

(similar to that of nonsmokers) rapidly after stopping smoking. 

Key: DMSO = dimethyl sulphoxide. 

Source: Benowitz, 1989. 

activity to tar for Carlton compared with other cigarettes, but the difference 

was not near the values of 13.5, 15.4, and 7.3, which were predicted by FTC 

values. 

The data of Rickert and Robinson (1981) shown in Table 3 explain the 

discrepancy between measured and predicted tar-to-nicotine ratios. These 

data, based on smoking machine tests, show that when cigarettes are smoked 

more intensely, the tar-to-nicotine ratio of low-yield cigarettes increases 

substantially. Thus, when smokers compensate for low-yield cigarettes by 

smoking them more intensely, the tar-to-nicotine ratio increases. Therefore, 

tar-to-nicotine ratios published by the FTC method cannot be used to make 

estimates of what the overall tar exposure will be for actual smokers. 

CONCLUSIONS The suggestion that there is a meaningful quantitative relationship 

between FTC-measured yields and actual intake is misleading. There do 

appear to be differences in nicotine exposure comparing high- vs. low-yield 

106 
Chapter 7 

Figure 9 

Average urine mutagenicity and ratio of mutagenic activity to nicotine exposure for subjects in 

high-low yield (Group 1) and high-ultralow yield (Group 2) studies 

Group 1 Grc ,2 

Urine Mutagenic Ratio Mutagenic Urine Mutagenic Ratio Mutagenic 

Activity Activity/AUC., Activity Activity/AUC,, 

(x 1W rev./24 hours) ( ) = FfC -tar/nic. ratio (x 1W rev./24 hours) ( ) = FTC -tar/nic. ratio 

( ) = FfC -tar (mg) N = 11 ( ) = FfC -tar (mg) N=ll 

12 T 50 roT 

40 T T 

30 

O H L O H L 0 H UL 0 H UL 

'Indicates significant difference @ c .05,repeated measures analysis of variance) compared with own brand. 

blndicates significant difference compared with high-yield cigarettes. 

Note: Despite lower ratios of tar and nicotine based on FTC testing for low- and ultralow-yield cigarettes, ratios of 

mutagenic activiiy to nicotine exposure were not different while subjects smoked high-, low-, or ultralow-yield 

cigarettes. Also, bars indicate standard error of the mean. 

Key: AUC,, = ratio of mutagenic activity to nicotine exposure; rev = revertant colonies; nic = nicotine; 0 = smoker's 

own brand; H = high-yield cigarettes (Camel); L = low-yield cigarettes (True); UL = ultralow-yield kigarettes 

(Cambridge or Carlton). 

Source: Benowitz et a/., 1986b. 

Table 3 

Influence of intensity of smoking on tar-to-nicotine ratio, based on smoking machine studies 

Standard Yield Tar-to-Nicotine Ratio Under 

(mg) Different Smoking Conditions 

Group N Tar Nicotine Standard Moderate Intensive 

I 4 <2 <2 9.2 9.9 ll.la 

II 10 2-5 0.2- 0.5 10.3 11 .7a 1 2.2a 

Ill 8 5- 10 0.5- 0.9 11.3 11.9 1 2.6a 

IV 9 10 - 14 0.8- 1 .O 12.7 1 3.3a 12.4 

V 5 14 - 17 0.9- 1 .o 15.7 1 6.5a 14.7 

a p c 0.05 compared with standard smoking machine conditions. 

Key: N = number of brands tested. 

Source: Rickert et al.. 1983. 

107 
Smoking and Tobacco Control Monograph No. 7 

cigarettes, but the differences are small and not quantitatively proportional 

to nominal yield. Tar and nicotine ratings are poor predictors of human 

intake, except for those cigarettes that happen to be rated by smoking 

machines as 1 mg nicotine per cigarette, in which case that rating 

fortuitously fits the population average. Tobacco manufacturers have 

stated that the FTC method was never intended to measure intake in any 

individual. The author agrees. However, data for 2,000 people summarized 

here indicate that the FTC method does not work for the general population 

of smokers either. 

In general, the FTC method underestimates human exposure. Smokingmachine-derived tar-to-nicotine ratios, which have been used to argue the 

benefit of switching to low-yield cigarettes, are not of value because these 

ratios change with changes in smoking behavior. On the other hand, 

because there is some relationship between yields and nicotine, and although 

the slope of that relationship is shallow, it is not recommended that smokers 

regress to smoking higher yield cigarettes. 

QUESTION-AND-ANSWER SESSION 

DR. RICKERT: When we first looked at this back in 1981, there was 

absolutely no relationship between yields and uptake as measured by 

cotinine. And then, as you follow the studies from 1981 through to 1994, 

there seems to be a growing tendency toward an association of some sort, 

and at the end you pointed out there was a shallow slope. Is this just a 

spurious change with time, or do you feel this may be related to changes in 

product characteristic because, obviously, the product that was smoked in 

1981 is not the product that is smoked in 1994. 

DR. BENOWITZ: Yes, when you look at the earlier studies, they show 

basically the same slope that studies that were done in 1989 and 1990 are 

showing. So, I think when we have a large enough population, we are 

probably seeing it even back in the 1980’s. Prior to that, I have no idea. 

DR. BOCK Dr. Benowitz, you were quoted as saying something to the effect 

that compensation over the long term does not appear to be persistent. Is 

that your opinion? 

DR. BENOWITZ: That statement was made in dealing with the question of 

when people are shifting from one cigarette to a lower yield cigarette, will 

there be permanent overcompensation? And the only studies that I found (I 

think Dr. Kozlowski is going to talk about these) looked at carbon monoxide 

levels and the amount of compensation. At least in one study, carbon 

monoxide levels went up and then went down again. 

But if you look at the issue of compensation broadly, how do you 

interpret the fact that people smoke a cigarette with an FTC yield of .2 the 

same as the one that has the FTC nicotine yield of 1.5, and they have the 

same nicotine cotinine levels? If you do not call it compensation, you have 

to think of something to call it. 

108 
Chapter 7 

At some point in time, I do think people will be limited by how much 

smoke they take into their lungs. I do not think it is relevant to modern 

cigarettes as currently marketed, but it could be relevant to a low-nicotine 

cigarette. 

DR. BOCK: You made a distinction just now and said “overcompensation.” 

Is that what you intend to imply? 

DR. BENOWITZ: Yes. 

DR. BOCK: Because there is a little bit of a difference between 

overcompensation and compensation. 

DR. BENOWITZ: Yes, I know. It is a good point. 

DR. HATSUKAMI: In the studies where you looked at the FTC yield and the 

actual intake, have any of the studies differentiated people who actually 

initiated with low-tar and low-nicotine cigarettes and those who switched? 

Are there any differences in terms of slopes between those two groups of 

people? 

DR. BENOWITZ: I have never seen that, but obviously that is a very 

interesting question in terms of initiation. The earlier data that we heard 

from Dr. Giovino suggest that most low-yield cigarette smokers are people 

who switched from higher yield, which I think is quite interesting. But I 

do not know the percentage of people who start with low-yield cigarettes. 

It would be a good question. 

DR. DEBETHIZY: Would you say that, on average, the people who smoke 

lower yielding cigarettes absorb less nicotine? 

DR. BENOWITZ: Yes, but the slope is very shallow. 

DR. DEBETHIZY: So, if people are smoking very low-yielding cigarettes, they 

are absorbing less nicotine and the data do speak to that. So, compensation 

is incomplete; there is not a flat line. 

One of the studies that you pointed out up there said that people 

absorbed, on average, 1mg of nicotine from cigarettes. And I think that 

it is important to point out that people who smoke lower yielding cigarettes 

do absorb less nicotine. 

DR. BENOWITZ: Yes, although it is unclear where the break is. Some of our 

data have suggested that the break is actually with the very, very low-yield 

cigarettes, rather than the cigarettes most people smoke. But I would accept 

the fact that there is a shallow relationship. Understand, however, that you 

are talking about a 10-percent variation in nicotine intake, going across 

yields from 0.1 to 1.6. So, there is some reduction in nicotine intake per 

cigarette on average, but it is very small. 

DR. DEBETHIZY: The other point I want to make is, you do rightfully point 

out that I will discuss a little later why our study, which is the Byrd study, 

may be unique from the plasma cotinine studies, in the fact that it is done 

109 
Smoking and Tobacco Control Monograph No. 7 

with a completely different method and what we think is a more precise 

method. 

DR. WOOSLEY: I think the point you make is that the predictive accuracy of 

any yield numbers, except at the low end of the scale, is useless, and I think 

that is the most important message that I got out of your presentation. 

The other message I have gotten out of the presentation was that this 

indicates that the differences in mortality that we saw earlier, which had the 

potential to be confounded, are very likely to be confounded because of the 

lack of a difference in exposure that your data indicate. 

DR. BENOWITZ: I would certainly agree with that. On the coronary heart 

disease data, for example, with the low-yield cigarettes, I think you can 

virtually assume that their exposure to everything was substantially the same. 

It is no surprise that there is no protective effect of smoking low-yield 

cigarettes for heart disease. 

DR. RICKERT How relevant do you feel the absorption of nicotine is to the 

levels of other harmful constituents, such as benzo(a)pyrene and biphenyl, 

which are probably more related to disease processes than nicotine per se? 

DR. BENOWITZ: I think there is considerable variability, and one has to look 

at that issue. I don't think there are enough data to know for the range of 

products. 

REFERENCES 

Benowitz, N.L. Pharmacologic aspects of cigarette 

smoking and nicotine addiction. New England 

Iournal ofMedicine 319: 1318-1330,1988. 

Benowitz, N.L. Dosimetric studies of compensatory 

cigarette smoking. In: Independent Scientific 

Committee on Smoking and Health: Nicotine, Smoking, 

and the Low Tar Programme, London, November 18-

20, 1986, N. Wald and P. Froggatt (Editors). Oxford: 

Oxford University Press, 1989, pp. 133-150. 

Benowitz, N.L., Hall, S.H., Heming, R.I., Jacob, P. 111, 

Jones, R.T., Osman, A.-L. Smokers of low-yield 

cigarettes do not consume less nicotine. New 

England Journal of Medicine 309: 139-142, 1983b. 

Benowitz, N.L., Jacob, P. 111. Daily intake of nicotine 

during cigarette smoking. Clinical Pharmacology and 

Therapeutics35: 499-504, 1984a. 

Benowitz, N.L., Jacob, P. 111. Nicotine and carbon 

monoxide intake from high- and low-yield 

cigarettes. Clinical Pharmacology and Therapeutics 

36: 265-270,1984b. 

Benowitz, N.L., Jacob, P. 111. Nicotine renal excretion 

rate influences nicotine intake during cigarette 

smoking. lournal of Pharmacology and Experimental 

Therapeutics234: 153-155,1985. 

Benowitz, N.L., Jacob, P. 111. Metabolism of nicotine to 

cotinine studied by a dual stable isotope method. 

Clinical Pharmacology and Therapeutics 56(5): 483- 

493,1994. 

Benowitz, N.L., Jacob, P. 111, Denaro, C., Jenkins, R. 

Stable isotope studies of nicotine kinetics and 

bioavailability. Clinical Pharmacology and 

Therapeutics 49: 270-277, 1991. 

Benowitz, N.L., Jacob, P. HI, Fong, I., Gupta, S. 

Nicotine metabolic profile in man: Comparison 

of cigarette smoking and transdermal nicotine. 

Iournal of Pharmacology and Experimental 

Therapeutics 268: 296-303, 1994. 

Benowitz, N.L., Jacob, P. 111, Kozlowski, L.T., Yu, L. 

Influence of smoking fewer cigarettes on exposure 

to tar, nicotine, and carbon monoxide. New 

England journal ofMedicine 315: 1310-1313, 1986a. 

Benowitz, N.L., Jacob, P. 111, Yu, L., Talcott, R., Hall, 

S., Jones, R.T. Reduced tar, nicotine, and carbon 

monoxide exposure while smoking ultralow- but 

not low-yield cigarettes. lournal of the American 

Medical Association 256: 241-246, 1986b. 

Benowitz, N.L., Kuyt, F., Jacob, P. Ill, Jones, R.T., 

Osman, A.-L. Cotinine disposition and effects. 

Clinical Pharmacology and Therapeutics 34: 604-61 1, 

1983a. 

Byrd, G.D., Robinson, J.H., Caldwell, W.S., 

DeBethizy, J.D. Comparison of measured and 

FTC-predicted nicotine uptake in smokers. 

Psychopharmacology 122: 95-103, 1995. 

110 
Chapter 7 

Coultas, D.B., Stidley, C.A., Samet, J.M. Cigarette 

yields of tar and nicotine and markers of exposure 

to tobacco smoke. American Rmkw ofRespiratory 

Diseuse 148: 435-440,1993. 

Ebert, R.V., McNabb, M.E., McCusker, K.T., Snow, S.L. 

Amount of nicotine and carbon monoxide inhaled 

by smokers of low-tar, low-nicotine cigarettes. 

Journal of the Ammican Medical Association 250: 

28404842,1983. 

Gori, G.B., Lynch, C.J. Smoker intake from cigarettes 

in the 1mg Federal Trade Commission tar class. 

Regulatory Toxicology and Pharmacology 3: 110-120, 

1983. 

Gori, G.B., Lynch, C.J. Analytical cigarette yields as 

predictors of smoke bioavailability. Regulatory 

Toxicology and Pharmacology 5: 314-326, 1985. 

Jarvis, M., Tunstall-Pedoe, H., Feyerabend, C., Vesey, 

C., Salloojee, Y. Biochemical markers of smoke 

absorption and self reported exposure to passive 

smoking. Journal of Epidemiology and Community 

Health 38(4): 335-339, 1984. 

Rickert, W.S., Robinson, J.C. Estimating the hazards of 

less hazardous cigarettes. 11. Study of cigarette yields 

of nicotine, carbon monoxide, and hydrogen 

cyanide in relation to levels of cotinine, 

carboxyhemoglobin, and thiocyanate in smokers. 

Journal of Toxicology and Environmental Health 7: 

391-403, 1981. 

Rickert, W.S., Robinson, J.C., Young, J.C., Collishaw, 

N.E., Bray, D.F. A comparison of the yields of tar, 

nicotine, and carbon monoxide of 36 brands of 

Canadian cigarettes tested under three conditions. 

Preventive Medicine 12:682-694, 1983. 

Rosa, M., Pacifici, R., Altieri, I., Pichini, S., Ottaviani, 

G., Zuccaro, P. How the steady-state cotinine 

concentration in cigarette smokers is directly 

related to nicotine intake. Clinical Pharmacology 

and Therapeutics 52: 324-329, 1992. 

Russell, M.A., Jarvis, M.J., Feyerabend, C., Saloojee, Y. 

Reduction of tar, nicotine and carbon monoxide 

intake in low tar smokers. Journal of Epidemiology 

and Community Health 40(1): 80-85, 1986. 

Russell, M.A.H., Jarvis, M., Iyer, R., Feyerabend, C. 

Relation of nicotine yield of cigarettes to blood 

nicotine concentrations in smokers. British Medical 

Journal 5: 972-976,1980. 

Yamasaki, E., Ames, B.N. Concentration of mutagens 

from urine by absorption with the nonpolar resin 

XAD-2 Cigarette smokers have mutagenic urine. 

Proceedings of the National Academy of Sciences of the 

United States 74: 3555-3559, 1977. 

ACKNOWLEDGMENTS This research was supported by grants DA-02277, CA-32389, 

DA-01696, and RR-00083 from the National Institutes of Health. The author 

thanks David Greene for editorial assistance. 

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BLANK PAGE 
Chapter 8 

Pharmacology and Markers: Nicotine 

Pharmacology and Addictive Effects 

Jack E. Henningfield and Leslie M. Schuh 

INTRODUCTION Dosing characteristics of cigarette brands are estimated using 

machines that smoke representative cigarettes from each brand according 

to a protocol termed the Federal Trade Commission (FTC) method (Peeler, 

this volume; Pillsbury, this volume). This technology and methodology 

provide tar- and nicotine-dosing estimates of cigarettes that are misleading 

to consumers and do not accurately predict what level of tar and nicotine 

intake consumers will obtain by smoking a given brand of cigarettes 

(Henningfield et al., 1994). An understanding of the dependence-producing 

and other behavior-modifying effects of cigarette smoke is necessary to 

understand why the FTC method is a poor predictor of the nicotine, tar, 

and carbon monoxide levels people obtain from cigarettes. Cigarette 

smoking behavior is influenced by nicotine dose, and smokers tend to 

maintain nicotine intake within upper and lower boundaries (Kozlowski, 

1989). In brief, nicotine produces dose-related tolerance, physical 

dependence, and discriminative effects (i.e., effects that people can feel, 

which modify mood and physiology), and smokers change their behavior 

in response to these effects. Unlike human smokers, machines are not 

nicotine dependent, nor do they modify their behavior based on the flavor 

of the smoke. 

The FTC method was developed in the 1960's to provide a relative 

ranking of nicotine, tar, and carbon monoxide yields from various cigarettes 

(Peeler, this volume; Pillsbury, this volume). This ranking has provided 

consumers with the false sense that they can tell precisely the amount of 

these substances they will obtain from a given cigarette. Since the 1960's 

there have been many advances in the understanding of nicotine and 

smoking behavior that can be useful in reforming this methodology. This 

chapter provides an overview of relevant research, including (1) physiological 

and behavioral pressures to sustain nicotine intake; (2) the relationship 

between smoking and nicotine dose; (3) determinants of compensatory 

behavior, including the role of nicotine and other factors, such as flavor; 

and (4) measurement of smoking and nicotine intake. 

CIGARETTE Several findings bear on the issue of the strength of dependence 

SMOKING AS on cigarettes. Although 70 to 90 percent of smokers are 

DRUG DEPENDENCE interested in quitting, only one in three succeeds before age 65 

(Fiore, 1992). There is good and bad news about coronary 

Addiction Severity bypass surgery and even a lung removal. The good news is 

that these traumatic events are among the most powerful incentives to quit 

smoking. If one intervenes with patients who undergo these procedures, 

about one-half of them quit. However, the bad news is that the other half 

113 
Smoking and Tobacco Control Monograph No. 7 

or more soon return to smoking (U.S. Department of Health and 

Human Services, 1988). There are two lessons here. First, incentives and 

motivation are important factors in the treatment of nicotine and other 

drug dependencies. Second, incentives and motivation have limitations; 

even the threat of death is not sufficient for half these smokers to stop 

smoking. 

This is a tenacious addiction in which, despite so many people wanting 

and trying to quit, fewer than 1in 10has a 1-year success, and this means 

that only 2 to 3 percent of smokers stop smoking each year (Fiore, 1992). 

Indeed, as Kozlowski and colleagues (1989) show, more than half of heroin 

and cocaine users and alcoholics rate smoking cigarettes as harder to give 

up than these other drugs. Thus, there are strong biological pressures in 

nicotine-dependent humans that do not exist in machines to sustain 

addictive levels of nicotine intake. 

Clinical As with dependence on other drugs, cigarette smoking tends to be a 

Characteristics progressive, chronic, relapsing disorder (U.S. Department of Health 

and Human Services, 1988). The most notable distinction between cigarette 

smoking and other drug dependencies is that a much higher percentage of 

people who start smoking escalate and graduate to dependent levels than 

with other addictive drugs. About 1in 10 smokers in this country is a lowlevel smoker, termed a “chipper,” who smokes 5 or fewer cigarettes per day 

(U.S. Department of Health and Human Services, 1988); most of the rest 

show evidence of dependence. This is in contrast to alcohol use, where 

10to 15 percent of alcohol drinkers are problem drinkers; the rest generally 

drink in moderation and at times of their own choosing (U.S. Department 

of Health and Human Services, 1988). 

People do not start smoking a pack of cigarettes per day. They likely 

would become ill at that level of nicotine intake. Rather, they start out 

with low levels. Over months and years, most people progress to higher 

and higher nicotine intake. They become tolerant; that is, nicotine loses 

effectiveness with its continued presence in the body, and it is necessary to 

increase the dose to maintain its effectiveness after repeated administrations. 

Eventually, smokers do more than simply tolerate high nicotine doses; they 

need continued nicotine to feel normal and function satisfactorily. At this 

point, smokers may go to great lengths to continue smoking and sustain 

their nicotine intake within upper and lower boundaries so that their intake 

does not fall low enough that they experience withdrawal symptoms or 

high enough to produce adverse effects (Kozlowski, 1989). 

An important aspect of the chronic nature of tobacco dependence is 

related to daily patterns of nicotine blood levels. When smokers wake up 

in the morning, some residual nicotine remains in their blood from smoking 

on the previous day. Blood concentrations rise as they smoke until, by 

midafternoon, most smokers’ intake equals metabolism and excretion, and 

nicotine level stabilizes. Levels fall rapidly overnight, and the cycle resumes 

the next day. Thus, blood concentrations never reach zero unless the person 

quits smoking for more than a few days. Moreover, cotinine, an active 

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Chapter 8 

NICOTINE 

DELIVERY 

SYSTEMS 

nicotine metabolite, has a half-life of about 20 hours (Cummings and 

Richard, 1988; Jarvis, 1989; Jarvis et al., 1987) and therefore persists in the 

body even longer. 

It is difficult to disrupt these patterns when people have access to 

cigarettes. In a study by Benowitz and colleagues (1986a), people switched 

from 30 to 5 cigarettes per day. Because they tended to smoke these 

5 cigarettes much more intensely, they reduced carbon monoxide levels 

by only one-half and nicotine levels by only about one-third. Thus, nicotine 

intake remained high enough to sustain dependence. 

After quitting smoking, most people relapse quickly, and about one-third 

of the people who have quit smoking and remained abstinent for 1year 

relapse (Fiore, 1992). As with alcohol and heroin, most nicotine relapses 

occur during the first 3 months of abstinence (Hunt et al., 1971). In fact, the 

determinants of relapse (eg, degree of dependence and negative emotional 

states) and remission (e.g., substance-associated health problems and learning 

to manage cravings) are also similar across these three classes of drug 

dependence (U.S. Department of Health and Human Services, 1988). 

Relapse to nicotine dependence has been studied in greater detail than 

relapse to heroin, cocaine, and alcohol dependence. Data from a Mayo Clinic 

study showed that, with minimal treatment intervention, one-quarter of the 

people relapsed in 2 days and about one-half in the first week (Kottke et al., 

1989). More recent data on people who quit on their own showed that about 

two-thirds relapse within 3 days (Hughes et al., 1992). The withdrawal 

syndrome can be debilitating in its own right, but in the long run, its worst 

health consequences may be that most efforts to quit smoking never survive 

the withdrawal phase (Hughes et al., 1992), thereby dooming one-half of 

persistent smokers to die prematurely because of their tobacco use (Peto et al., 

1994). Much of the benefit of current nicotine medications is providing 

adequate nicotine replacement for that formerly provided by cigarettes to 

help more people remain nonsmokers during the important first few weeks 

of tobacco abstinence. 

Tobacco products come in many different forms. All have toxicities and 

dependence potential, and there is variation related to the type of tobacco 

product and route of administration. Although the focus here is on 

cigarettes, at some point similar issues must be addressed with other tobacco 

products that currently have no dosage labeling. For example, moist snuff 

products vary widely in their nicotine-dosing capabilities, and there is 

evidence that the variation is accomplished primarily by manipulation 

of the pH level of the products by tobacco manufacturers (Henningfield 

et al., 1995; Djordjevic et al., 1995), but neither tobacco companies nor 

governmental agencies provide any form of nicotine dosage information 

to consumers except in cigarette advertising. 

The cigarette, which may be conceived of as a nicotine dispenser with 

smoke as the vehicle, is the most toxic and dependence-producing form of 

nicotine delivery. Nicotine is volatilized at the tip of a burning cigarette from 

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Smoking and Tobacco Control Monograph No. 7 

which it is carried by particulate matter (tar droplets) deep into the lungs 

with inspired air. The nearly 2,000 OF microblast at the cigarette’s tip is also 

the source of carbon monoxide and many other toxicologically significant 

pyrolysis products. Nicotine is rapidly absorbed in the alveoli of the lungs, 

concentrated in the pulmonary veins as a bolus, and pumped by the left 

ventricle of the heart throughout the body. Absorption characteristics are 

similar to those of gases, such as oxygen, that are exchanged in the lung 

from inspired air to venous blood (Henningfield et al., 1993). Thus, smoke 

inhalation produces arterial boli that may be 10 times more concentrated 

than the levels measured in venous blood (Henningfield et al., 1990 and 

1993). 

Psychoactive effects have rapid onset and short duration, dissipating 

within a few minutes. This short duration requires the user to self-administer 

the drug repeatedly, perhaps taking hundreds of puffs per day. The cigarette 

allows the smoker very fine, “fingertip,” dose control. The powerful engulfing 

sensory effects are also important in dependence. It is not just the drug but 

the conditions and the cues that become associated with the drug that make 

nicotine dependence so tenacious. Finally, the cigarette is a convenient, 

portable system that permits easily repeated dosing. 

Benowitz (this volume) reviewed the pharmacokinetics of various 

nicotine delivery systems. Briefly, a cigarette produces a rapid spike of 

nicotine in the arterial blood. Smokeless tobacco products are also rapid, 

especially the higher pH tobacco products, and they require little practice 

for the user to achieve high nicotine levels. Whereas the nicotine dose 

obtained from a cigarette is largely determined by the behavior of the user, 

the nicotine dose obtained from a “chew” of smokeless tobacco is largely 

controlled by the product (Henningfield et al., 1995). In contrast to delivery 

from tobacco products, delivery of nicotine from polacrilex (nicotine gum) 

is slower and takes a great deal of practice and work to achieve even modest 

nicotine plasma levels. Transdermal nicotine medications (patches) provide 

slow absorption-so slow that users cannot reliably detect nicotine’s effects. 

The speed of delivery is clearly an important determinant of addictive effects, 

and the cigarette, like crack cocaine, provides an explosive dose of nicotine. 

NICOTINE’S Nicotine is a fascinating psychoactive drug. It was used to help map the 

EFFECTS cholinergic nervous system early in the 20th century. Much of receptor 

theory and many of the methods used to study competitive agonists and 

antagonists were developed at the turn of the century using nicotine (Langley, 

1905). 

Nicotine has diverse effects, not only in the brain but also in the 

adrenals and skeletal muscles. These diverse effects may explain why a 

smoker reports that on some occasions cigarettes have relaxing effects and on 

other occasions, stimulating effects. This has been referred to as a paradoxical 

effect, but it is not paradoxical at all; other drugs generally referred to either 

as sedatives or stimulants also produce both sedating and stimulating effects 

(Gilman et al., 1990). Like the effects of these other drugs, nicotine’s effects 

are complicated; they depend on the dose, the time since dosing, how the 

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Chapter 8 

drug was administered, which responses are being measured, and other 

factors (Henningfield and Keenan, 1993; Pomerleau and Rosecrans, 1989). 

If people with histories of drug abuse are given nicotine, they like the 

nicotine; that is, liking scale scores increase with greater doses within a 

certain range of parameters (Henningfield et al., 1985). Among drug abusers, 

similar findings are reported for morphine and amphetamines but not for 

drugs that have little psychoactivity (Fischman and Mello, 1989). Such 

psychoactive effects are predictive of addiction potential and are correlated 

with the ability of a drug to serve as a reinforcer for animals and humans 

(Griffiths et al., 1980). Nicotine is psychoactive in humans and is readily 

discriminated by animals; several forms of nicotine delivery have been shown 

to serve as reinforcers for animals and humans (U.S. Department of Health 

and Human Services, 1988). 

Physical The cellular and neurological changes that lead to tolerance 

Dependence also lead to physical dependence so that when people abruptly 

and Withdrawal discontinue tobacco use, withdrawal occurs (U.S. Department of 

Health and Human Services, 1988). Withdrawal onset begins within a few 

hours of the last cigarette; symptoms include decreased cognitive capabilities 

and heart rate and increased dysphoria or depressed mood, insomnia, 

craving, anxiety, irritability, restlessness, appetite, and tendency to smoke 

(American Psychiatric Association, 1994; Hughes and Hatsukami, 1992). 

Altered brain electrical potentials and hormonal output are generally opposite 

in direction of those produced by acute nicotine administration, and 

decrements in evoked electrical potentials of the brain indicate impaired 

information processing capabilities (Pickworth et al., 1989; U.S. Department 

of Health and Human Services, 1988). 

Nicotine dependence seems to be mediated primarily by the activation 

of nicotinic cholinergic receptors in the brain (U.S. Department of Health 

and Human Services, 1988) and secondarily through the cascading effects 

of nicotinic systems to modulate levels of hormones such as epinephrine 

(adrenaline) and cortisol (Pomerleau and Pomerleau, 1984; U.S. Department 

of Health and Human Services, 1988). The mesolimbic dopaminergic 

reward system, which mediates the ability of cocaine to produce dependence, 

also has been implicated in nicotine dependence (Corrigall, 1991; U.S. 

Department of Health and Human Services, 1988). The cells of this system 

are located in the ventral tegmental area of the midbrain. Axons project to 

the limbic system-specifically, to the nucleus accumbens, olfactory tubercle, 

nuclei of the stria terminalis, and parts of the amygdala. Behaviors followed 

by such neural activation can become extremely persistent. Cortical effects 

of nicotine administration include changes in local cerebral metabolism 

(London and Morgan, 1993) and electroencephalogram results aones, 1987). 

Prominent endocrine effects include release of catecholamines, serotonin, 

prolactin, growth hormone, arginine vasopressin, beta-endorphin, and 

adrenocorticotropic hormone (Pomerleau and Pomerleau, 1984; U.S. 

Department of Health and Human Services, 1988). These effects mediate 

both the positive nicotine reinforcement sought by smokers and even 

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Smoking and Tobacco Control Monograph No. 7 

animals (Corrigall, 1991; Henningfield and Goldberg, 1983; Pomerleau, 1992; 

U.S. Department of Health and Human Services, 1988) and the negative 

reinforcement of withdrawal symptoms that also fuel the compulsion to 

smoke (Hughes and Hatsukami, 1992; Pomerleau and Pomerleau, 1984). 

Nicotine also produces increased expression of brain nicotinic receptors in 

humans and animals (U.S. Department of Health and Human Services, 1988). 

Taken together, these physiologic effects confirm that nicotine exposure alters 

the structure and function of the nervous system and leads to modification of 

behavior. Thus, there are physiological factors that drive smokers to sustain 

continued nicotine intake across changing delivery systems. 

Smokers may report that they feel impaired and distracted after only 

a few hours of abstinence, and their performance on various cognitive and 

psychomotor tasks can decline within approximately 4 hours (Heishman et 

al., 1994). Symptoms are rapidly reversed with resumed smoking or nicotine 

replacement, thus providing a potentially powerful source of reinforcement 

for continued smoking. The degree of reversal is generally proportional to 

the percentage of plasma nicotine that is replaced (Pickworth et al., 1989; 

U.S. Department of Health and Human Services, 1988). 

Data from a performance study indicated that when patients abstained 

from cigarettes and used placebo gum, they made more errors and took 

longer to complete a task than during their smoking baseline. When they 

were given 2 mg gum, their performance returned to baseline. With 4 mg 

gum, they did not do significantly better than at baseline, but 4 mg appeared 

to produce somewhat more reliable clinical effects than 2 mg (Snyder and 

Henningfield, 1989). 

The same pattern of effects occurs with theta power, a measure of brain 

function (Pickworth et al., 1989). This nicotine-withdrawal-induceddeficit 

can be completely reversed with nicotine replacement. When other 

volunteers resumed smoking, electrocortical potentials recovered quickly 

in all volunteers. Interestingly, these people did not like the gum, and they 

were not trying to quit smoking. The lesson is that nicotine replacement 

can maintain physiological function and cognitive performance. The 

conclusion relating to performance is not that nicotine makes the user 

perform better, faster, or more intelligently but that nicotine deprivation 

results in impairments that are quickly and dose-dependently reversed by 

nicotine readministration (Heishman et al., 1994). 

The nicotine-withdrawal-induceddecline in performance has practical 

ramifications in policy decisions. Currently, the Federal Aviation 

Administration is examining its policies on smoking by pilots in the 

flight decks of commercial airlines. Because of the time course of nicotine 

withdrawal, if smoking were eliminated in the flight deck, acutely deprived 

pilots might suffer withdrawal-induced performance declines on flights 

longer than approximately 4 hours. Thus, the nicotine withdrawal syndrome 

poses a potential safety hazard if it is not rationally addressed by appropriate 

strategies to detoxify pilots safely and treat their withdrawal symptoms with 

nicotine replacement medications. 

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Chapter 8 

The duration of the nicotine withdrawal syndrome varies across 

individuals, but on average, the acute physical syndrome is worst during 

the first month. Gross and Stitzer (1989) studied the time course of the 

nicotine withdrawal syndrome in detail. In their study, people quit smoking 

and received either active or placebo nicotine gum. People who received 

active gum chewed an average of 6.9 pieces of 2 mg gum per day, which 

provided less nicotine than they were obtaining by smoking cigarettes. 

People given placebo gum gradually decreased their intake from 6.8 pieces 

per day during the first week of treatment to 4.9 pieces per day by the 

10th week. The nicotine gum substantially reduced withdrawal symptom 

severity relative to that observed in placebo subjects. 

Nicotine’s Nicotine provides many effects that cigarette smokers may consider useful. 

Beneficial These include weight control, mood control, and preventing withdrawal 

Effects symptoms (U.S. Department of Health and Human Services, 1988). The 

issue of whether nicotine would provide substantial cognitive enhancement 

in healthy persons who had never been nicotine dependent is controversial. 

In nonsmokers, nicotine administration can increase finger-tapping rate 

and slightly (but significantly in some studies) attenuate the deterioration 

in attention that occurs during protracted testing (Heishman et al., 1994). 

However, complex cognitive performance may be impaired by nicotine in 

cigarette smokers as well as nonsmokers (Heishman et al., 1994). On the 

other hand, there is no question that nicotine intake restores withdrawalinduced deficits (Snyder and Henningfield, 1989). Nicotine intake also may 

provide some level of cognitive enhancement in persons who are cognitively 

impaired by Alzheimer’s disease (Heishman et al., 1994; Sahakian et al., 1989; 

Newhouse and Hughes, 1991). 

One of the Brown and Williamson Tobacco Corporation (BSTW) 

documents made available for the National Cancer Institute conference on 

the FTC cigarette test method also supported the conclusion that nicotine’s 

central nervous system effects contribute to the strong motivation to use 

tobacco products. The document concluded that 

to understand smoking, just as any other behavior, it is necessary 

to consider it as a process embedded within everyday life . . . . It 

is apparent that nicotine largely underpins these contributions 

through its role as a generator of central physiological arousal 

effects which express themselves as changes in human 

performance and psychological well being. (Brown and 

Williamson, 1984) 

SMOKING AND Nicotine dosage is an important factor in smoking behavior. 

NICOTINE DOSE Currently available cigarettes allow people to fairly easily administer 

the nicotine dose they need or desire (Henningfield et al., 1994). This was 

true of a low-content cigarette, NEXT, that was marketed a few years ago and 

removed from the market following poor sales, even though taste and draw 

characteristics were similar to conventional cigarettes. With that cigarette, 

the nicotine content was so low that no amount of compensatory puffing 

119 
Smoking and Tobacco Control Monograph No. 7 

and inhaling could result in the extraction of substantial amounts of nicotine 

(Butschky et al., 1995). 

Compensatory Compensation is nicely described in the B&W documents (Brown and 

Behavior Williamson, 1984) as “the tendency for a smoker to obtain similar 

delivery, intake and uptake of smoke constituents on a daily basis from a 

variety of products with different standard (machine-smoked) deliveries.” 

As the B&W researchers noted, if smokers are dependent, then the 

nicotine they receive from cigarettes can be supplemented by other forms, 

and this will reduce smoking. Likewise, cigarettes of different strengths are 

smoked differently; that is, smokers given low-delivery cigarettes smoke 

them more intensively and vice versa. 

In fact, this is what has been found in many studies (U.S. Department 

of Health and Human Services, 1988). Cigarette consumption increases 

in response to reduced nicotine, and most compensation occurs at the 

individual cigarette level, not by cigarettes per day. Whereas people given 

cigarettes of lower nicotine yield also may smoke a few more cigarettes 

per day, they smoke each of the cigarettes more intensely to obtain 

proportionately more nicotine than the rating of nicotine yield would 

suggest (Hill and Marquardt, 1980; Russell et al., 1980; Benowitz et al., 1983; 

Robinson et al., 1983). 

When people are given nicotine gum and their smoking is measured, 

smoking decreases as the nicotine gum dose increases (Nemeth-Coslett and 

Henningfield, 1986). When mecamylamine is administered to antagonize 

nicotine’s effects, people smoke more cigarettes, take more puffs per cigarette, 

and take in more total smoke, as can be seen by increased carbon monoxide 

level (Nemeth-Coslett et al., 1986; Rose et al., 1989). Taste and other sensory 

factors are also important modulators of human smoking behavior (Butschky 

et al., 1995; Rose and Behm, 1987; U.S. Department of Health and Human 

Services, 1988). 

This finding addresses why the nicotine dependence issue is relevant to 

why the FTC method of measuring tobacco smoke constituents is seriously 

flawed. Simply put, the FTC method uses machines that do not change their 

behavior to self-administer a preferred nicotine dose or in response to the 

taste of the smoke, as human smokers do. It may be an accurate predictor of 

what smoking machines obtain under specifically programmed conditions, 

but it is not an accurate predictor of what people get from cigarettes. 

The dose-response relationship between FTC ratings and plasma nicotine 

levels is weak, except at low doses (Russell et al., 1980 and 1986; Rickert and 

Robinson, 1981; Benowitz et al., 1983 and 1986b; Robinson et al., 1983; 

Gori and Lynch, 1985; Maron and Fortmann, 1987; Coultas et al., 1993). 

The relationship between cigarette dosage ratings and plasma nicotine levels 

may be better in studies using research cigarettes where nicotine content 

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Chapter 8 

varies. With other drugs, compensation can be diminished when the cost 

of compensation increases. That is, if a drug becomes too costly in terms of 

expense or physical difficulty in sustaining intake, users may not compensate 

as effectively and will not administer as much of the drug as they did when 

the cost was lower (U.S. Department of Health and Human Services, 1988; 

Lemaire and Meisch, 1985; Bickel et al., 1993). Thus, if cigarettes have low 

enough nicotine contents, smokers would be expected to adjust over time 

to lower nicotine levels rather than spend the time and money necessary to 

maintain constant dose intake. Conversely, most smokers probably would 

not smoke 160 to 200 low-nicotine-content cigarettes per day to continue 

to receive the intake that they previously obtained from conventional 

cigarettes. 

Measurement of The role of dependence is assumed by the authors and the tobacco 

Smoking and industry to be important determinants of nicotine intake. Brown 

Nicotine Intake and Williamson (1983) noted 

the basic assumption is that nicotine, which is almost 

certainly the key smoke component for satisfaction, is 

fully released to the body system before exhalation takes 

place. It is essential, therefore, to quantify the change 

in chemical composition between inhaled and exhaled 

smoke under different smoking conditions. 

Cigarette dose determination is indeed complicated, and some may 

suggest that it is so complex that use of the flawed FTC method might as 

well continue simply because it has been used for nearly 30 years. However, 

such a conclusion contradicts the enormous research advances made 

over the past 30 years. This research can be used to devise a better method. 

Furthermore, the complexity of dose determination is not unique to 

cigarettes. The Food and Drug Administration (FDA) faces this issue 

routinely whenever a manufacturer submits a new drug. Unless the drug 

is injected into a vein, determination of dosing is complicated. If the drug 

is delivered by an inhaler or oral capsule, many factors must be and are 

considered so that consumers are provided with realistic estimates of what 

they will get. In particular, they are provided with information relevant to 

the maximal doses that they are likely to receive from a drug-delivering 

product. 

To provide accurate dosing information for drug delivery systems, FDA 

uses different methods as indicated by the chemical and its delivery system; 

moreover, verification of dosing estimates is accomplished in human 

bioavailability testing studies because, in the final analysis, we care about 

the dose that people receive, not the machine-derived dose. Also, if there 

are factors that produce major changes in bioavailability, such as whether 

the drug is taken with food or on an empty stomach, this can be indicated 

in the labeling. 

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Smoking and Tobacco Control Monograph No. 7 

A PROPOSAL One approach to more meaningful cigarette labeling is that described 

FOR MORE by Henningfield and colleagues (1994). This approach was adapted 

MEANINGFUL from that used by FDA to label food products with constituents of 

CIGARETTE health-related relevance. One issue that FDA addressed in food 

LABELING labeling was serving size. In the case of cigarettes, research has 

indicated the need for larger and more intense puffs from the machine to 

more closely parallel smokers’ behavior (U.S. Department of Health and 

Human Services, 1988). A second issue for cigarette labeling is the need to 

use biologically meaningful categories. For example, labels might specify 

“no nicotine” or “low nicotine” instead of including numerical values that 

imply that differences of a few percentage points have practical meaning and 

provide the consumer with the illusion that she or he will obtain different 

doses from different cigarettes. Similarly, terms such as “light” should be 

banned altogether because they imply health benefits; these terms are 

permitted with foods only if the food type provides a health benefit relative 

to the conventional type of food in a given category. Actual nicotine 

content of the cigarettes also should be provided to consumers because the 

content determines the absolute limit of nicotine that could be extracted. 

Nicotine delivery ratings also could be linked to other factors having 

health effects, for example, tar. Thus, a low-nicotine-delivering cigarette 

could not be labeled “low nicotine” unless it was also low in tar and carbon 

monoxide delivery. A comparable situation in food labeling is that a label 

may not use the phrase “fat free” if a product contains cholesterol. Finally, 

nicotine yield estimates from standardized machine tests should be validated 

with bioavailability testing, as is done with other drugs, because what is of 

interest is the dose obtained by smokers. 

This approach would not in itself solve the health problem posed by 

tobacco use, but it would at least provide consumers with what they have 

come to expect in the United States, namely, honest labeling that gives them 

the information on which to make decisions about the products they use. 

Three decades of research on cigarette smoking, nicotine dependence, and 

measurement of tobacco constituent intake have provided the means to 

give consumers such information. 

QUESTION-AND-ANSWER SESSION 

DR. DEBETHIZY: Dr. Henningfield, you really did not speak very much 

to the FTC method, but I think it is important to point out that the FTC 

method was never intended to measure nicotine uptake. 

I also agree with you. I think we can do better in terms of measuring 

nicotine uptake when we want to do that. I think the methods that have 

been used in the past are estimates. I think the study that I will tell you 

about a little bit later is a step in that direction, and I will be looking 

forward to sharing that with you. 

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Chapter 8 

I would like to make a point about your proposal to measure content. 

I have heard that a number of times today, and we have to remember that 

people do not eat cigarettes; they smoke cigarettes. And there is no 

indication that people obtain the amount of nicotine that is contained 

in a cigarette. 

DR. HENNINGFIELD: On content, I think that the most important thing 

is bioavailability tests. Again, that is the gold standard: what people are 

likely to get and generally under maximum conditions. The importance 

of content, though, is that content limits the amount of nicotine that you 

can get. If it is not there, you cannot get it. 

DR. DEBETHIZY: I think the important thing is the FTC method is set up to 

provide relative ranking, so that consumers can get an idea of what different 

cigarettes will yield. It was not intended to measure uptake. 

Now, if you want to measure uptake and evaluate the FTC method, 

that is a different activity, and I think that we need to make sure that we 

distinguish those two activities. One is to provide a relative ranking. The 

FTC method has done an excellent job of that over the years. 

DR. HENNINGFIELD: I am not addressing the method, but I think it is pretq 

clear that it has not done a good job of telling people what they will have in 

their bloodstream. And that is what I am addressing: that what people get 

in their bloodstream does not bear much relation to the FTC yields. So, I am 

not sure how much use that has been. 

DR. HARRIS: I see the dispute as distinguishing between an ordinal ranking 

and a cardinal ranking. An ordinal ranking merely says one brand, to some 

degree, delivers more or less nicotine than another; whereas, a cardinal 

ranking would say, this brand delivers one-fifth as much or five times as 

much. 

And what I understand the dispute to be about is that the FTC ranking 

actually may preserve an ordinal ranking in the roughest sense, but it does 

not preserve the cardinal ranking. From what I can gather, a 10-percent 

increase in FTC nicotine corresponds with, at most, about a 2-percent 

increase in blood nicotine, roughly speaking, and that that is where the 

problem lies. 

DR. HENNINGFIELD: It is not even that good, because if the slope were 

constant, you could maybe say there is an ordinal ranking. That still may 

not tell you if it is meaningful if it was so trivial. But what Dr. Benowitz 

showed was if there is a break. 

In other words, at the ultralow end, those cigarettes are in a slightly 

different category. From the data I have seen, it is not even a meaningful 

ordinal ranking. It is a pretty flat ranking. The slope is, I would contend 

until proven otherwise, biologically trivial. 

123 
Smoking and Tobacco Control Monograph No. 7 

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126 
Chapter 9 

Consumer/Smoker Perceptions of Federal 

Trade Commission Tar Ratings 

Joel B. Cohen 

INTRODUCTION A telephone survey among a national probability sample of 

1,005 adults (502 men and 503 women) 18years of age and older was 

conducted between November 17 and 20,1994. Data were weighted by 

age, sex, geographic region, and race so that each respondent was assigned 

a single weight based on the relationship between the actual population 

proportions of the listed characteristics and the comparable sample 

proportions. 

The author’s estimate of every-day smoking (23 percent) matches current 

assessments of adult U.S. smoking prevalence (22 percent). When every-day 

and some-days smokers were combined, the current smoking percentage 

(28.7 percent) was slightly higher than the Centers for Disease Control and 

Prevention (CDC) (1994) comparable estimate of 26.5 percent for 1992. This 

sample reported somewhat higher current smoking percentages for females 

(29 percent) than did the 1992 CDC surveys (24.6 percent). Total smoking 

reported by whites (29 percent) was slightly higher than in the 1992 CDC 

surveys (27.2 percent), whereas total smoking reported by blacks in this 

sample (27 percent) was virtually identical (27.8 percent). A high percentage 

of those who report having attended but not graduated from college were 

some-days smokers. When added to every-day smokers, this total was 

substantially higher (36 percent) than that reported in the CDC surveys 

(24 percent) and was closer to the CDC estimate for high school graduates 

(31percent). College graduates in this sample were also somewhat more 

likely to smoke (19 percent compared with 15.5 percent reported in CDC 

surveys). Age breakdowns were not entirely comparable among the surveys, 

but the author’s sample reported a higher incidence of smoking among 

18-to 24-year-olds (32 percent compared with 26.4 percent). 

TAR LEVEL OF Table 1reports the tar levels of cigarettes last smoked, determined by 

CIGARETTES asking the brand, size, and other characteristics of the cigarette. These 

answers were compared with actual Federal Trade Commission (FTC) tar 

ratings. In 15 percent of the cases, respondents could not provide sufficiently 

detailed product information to make this comparison (“Cannot Determine” 

respondents). These respondents were likely to come disproportionately from 

lower tar categories. A four-category designation of tar levels was selected. 

It allowed for somewhat greater differentiation among lower tar users, had 

an equal number of rating scale points in each of the low-tar categories, and 

was consistent with a recently proposed four-category nicotine and tar rating 

system. Unweighted cell sizes for the five tar categories (including “Cannot 

Determine”) shown in Table 1were small: 28, 75, 70, 116, and 48 for those 

smoking cigarettes in the past 2 to 3 years. 

127 
Smoking and Tobacco Control Monograph No. 7 

Table 1 

Tar level (percent) of cigarette last smoked 

Tar Levels (mg) 

Smoker Classification Very Low Low Medium High Cannot 

(weighted data) (N) 1-5 6-10 11-15 16+ Determine 

Current Smokers 

Some-days smokers (56) 

Every-day smokers (232) 

9 

8 

34 

22 

9 

21 

23 

40 

25 

10 

Recent (2to 3 years) quitters (36) 11 11 25 28 25 

Those Smoking in the Past 2 to 3 Years 

All smokers (325) 

Male (152) 

Female (174) 

9 

5 

12 

22 

24 

21 

19 

13 

25 

35 

42 

29 

14 

17 

12 

White (268) 

Black (28) 

Hispanic (26) 

High school or less education (107) 

At least some college education (1 46) 

10 

0 

4 

6 

12 

23 

14 

15 

15 

32 

21 

18 

4 

21 

23 

31 

64 

58 

41 

30 

15 

4 

19 

18 

12 

Smokers of regular size cigarettes (1 45) 

Smokers of longer cigarettes (1 73) 

Smokers of soft pack cigarettes (1 80) 

5 

12 

13 

28 

19 

17 

11 

27 

22 

40 

32 

33 

16 

11 

16 

Smokers of hard pack cigarettes (1 33) 3 29 17 41 9 

Smokers of plain cigarettes (223) 

Smokers of menthol cigarettes (101) 

9 

8 

24 

20 

18 

23 

35 

38 

15 

12 

Fifty-eight percent of current smokers smoked a cigarette with 15 mg or 

less of tar, and 9 percent smoked a cigarette with 1to 5 mg of tar. Recent 

quitters tended to come from relatively higher tar categories, consistent 

with evidence suggesting that switching to the lowest tar cigarettes was a 

substitute for, rather than a stepping stone to, quitting. High-tar cigarette 

use was more frequent among males, blacks, and Hispanics and decreased 

markedly with educational attainment. 

KNOWLEDGE OF Those smoking cigarettes in the past 2 to 3 years were asked to tell 

ADVERTISED the interviewer the tar number of their most recently smoked 

TAR NUMBERS cigarette. Seventy-nine percent indicated that they did not know. 

This increased to about 90 percent for those having less than a high school 

education, smokers ages 55 and older, and black smokers. Respondents 

answering “do not know” then were asked to come as close as they could, 

and interviewers were to probe for their “best guess.” Fifty-eight percent still 

reported not knowing. 

Initial responses were slightly more likely to be underestimates (9 percent) 

than correct answers (defined as plus or minus 1mg from the actual tar level) 

128 
Chapter 9 

or overestimates (6 percent in both of the latter two categories). When 

probed responses were included in the analysis, there was a substantial 

increase in responses that underestimated tar levels (from 9 to 20 percent); 

there were only small changes in correct answers or overestimates. When 

actual tar numbers were regressed against respondents’ initial and probed 

answers, the relationships were weak (r = 26 and 20, respectively). 

Smokers of very-low-tar cigarettes had a much greater awareness of their 

cigarettes’ tar numbers. Thirty-nine percent of those who smoked 1-to 5-mg 

tar cigarettes were correct initially, increasing to 50 percent with probing. 

These figures stand in marked contrast to responses of smokers of cigarettes 

with 6 to 10mg tar, whose comparable percentages of correct responses were 

4 and 9 percent, respectively. 

To assess “knowledge in practice” (in addition to recall-based knowledge), 

half the members of the sample were asked whether a 16-mg (or, for the other 

half, a 5-mg) tar cigarette is lower in tar than most other cigarettes on the 

market. The correct answers are “no”for the 16-mg tar cigarette and “yes” 

for the 5-mg tar cigarette. Table 2 shows respondents’ answers cross-tabulated 

by the tar level of their most recently smoked cigarette. Whereas 35 percent 

of the smokers of 1- to 5-mg tar cigarettes did not know that a 16-mg tar 

cigarette was not lower in tar, between 55 and 66 percent of all other smokers 

either did not know or gave incorrect responses to this question. For those 

Table 2 

Interpretation of Federal Trade Commission tar numbers corresponding to lower tar levels 

Tar Levels (mg) 

Very Low Low Medium High Cannot 

Interpretations 1-5 6-10 11-15 16+ Determine 

Believe That a 16-rng Tar 

Cigarette Is Lower in Tar 

Than Most Other Cigarettes 

(N = 179) 

% Correct 

(1 4) 

65 

(36) 

45 

(40) 

44 

(64) 

34 

(25) 

32 

% Incorrect 0 10 10 16 12 

% Do not know 35 45 46 50 56 

Believe That a 5-mg Tar 

Cigarette Is Lower in Tar 

Than Most Other Cigarettes 

(N = 158) 

% Correct 

(1 4) 

15 

(39) 

34 

(30) 

44 

(52) 

27 

(23) 

25 

% Incorrect 13 10 14 19 16 

% Do not know 73 56 42 55 59 

129 
Smoking and Tobacco Control Monograph No. 7 

smoking cigarettes having more than 5 mg of tar, between 56 and 74 percent 

either did not know that a 5-mg tar cigarette was lower in tar than most other 

cigarettes or said that it was not lower (with 10 to 20 percent incorrect). 

SMOKERS’ Two approaches were used to better understand how smokers 

INTERPRETATIONS interpreted the advertised tar numbers. In the first, half the 

OF TAR NUMBERS sample members were asked whether a pack-a-day smoker could 

significantly lower his or her health risks due to smoking by switching from 

a 20-mg tar cigarette to a 5-mg tar cigarette; for the other half, the switch 

was to a 16-mg tar cigarette. In total, 56 percent of smokers thought that a 

switch to a 5-mg tar cigarette would significantly lower health risks, whereas 

28 percent thought that a switch to a 16-mg tar cigarette would significantly 

lower health risks. 

Table 3 cross-tabulates answers to these questions against the actual tar 

levels of smokers’ cigarettes. For the substantive shift to a 5-mg cigarette, 

light-to-heavy tar cigarette smokers are evenly divided between believing 

there would be a significant reduction in health risks and either believing 

this would not be the case or being unsure about this. Whereas more than 

60 percent of smokers did not think switching to a 16-mg tar cigarette would 

lead to a significant reduction in health risks due to smoking, a sizable 

proportion of light-to-heavy tar cigarette smokers either thought it would 

or did not know. 

Table 3 

Inferences (percent) about health risks as a result of switching to lower tar cigarettes 

Tar Levels (mg) 

Very Low Low Medium High Cannot 

Inference 1-5 6-10 11-15 16+ Determine 

Switching From a 20-mg to a 5-mg Tar Cigarette 

Would Significantly Reduce Health Risks 83 49 49 55 60 

Switching From a 20-mg to a 5-mg Tar Cigarette 

Would Not Significantly Reduce Health Risks 13 32 35 25 29 

Do Not Know 4 19 15 20 12 

Switching From a 20-mg to a 16-mg Tar Cigarette 

Would Significantly Reduce Health Risks 18 35 28 25 33 

Switching From a 20-mg to a 16-mg Tar Cigarette 

Would Not Significantly Reduce Health Risks 68 61 61 61 37 

Do Not Know 14 4 10 14 31 

Relative Difference in Health Risks Between Those 

Asked About Switching to a 5-mg and Those 

Asked About Switching to a 16-mg Tar Cigarette 65 14 21 30 27 

130 
Chapter 9 

The interpretation of data in Table 3 is complicated by almost certainly 

differing beliefs of smokers in the four tar categories regarding the risks of 

smoking a 20-mg tar cigarette and hence about the decrease in risk from 

any reduction in tar level. Because the belief factor is likely to be a constant 

in the two versions of this question, it is useful to examine the relative 

reduction in health risk (i.e., the difference in benefits between switching 

to the 5-mg tar alternative compared with the 16-mg alternative), shown in 

the last row of Table 3. Once again, the evidence points to a clear difference 

between smokers of cigarettes with 1to 5 mg of tar and all other smokers. 

These very-low-tar smokers believe that it takes a substantial reduction in 

tar yields to significantly reduce health risk, whereas this belief does not 

appear to be held by a substantial number of smokers in other categories. 

Unfortunately, this belief also may support a judgment that a substantial 

reduction in tar levels may be a reasonable substitute for quitting. 

In the second approach, we examined smokers’ understanding of the 

distinction between tar yield and delivery, together with their willingness to 

treat the numerical information as if it had ratio-scale properties rather than 

merely ordinal properties. Many of those supporting the dissemination of 

tar numbers have assumed that consumers would use these numbers in an 

ordinal fashion, essentially as if they were simply rank-ordered data. Ordinal 

scales do not possess the property that each numerical interval is of the same 

magnitude (i.e., the difference between 1and 2 being precisely equal to the 

difference between 10 and 11). The FTC method may produce tar ratings 

that have this interval scale property for tar yields, but it cannot be said to 

do so for actual deliveries of tar because smokers’ inhalation patterns seem 

to vary as they move lower on the scale. A ratio scale has the further property 

of having a genuine zero point so that it is proper to regard a scale score of 

10 as being twice as high as a scale score of 5. 

Respondents were asked to assume that a person switched from a 10-mg 

tar cigarette to a 1-mg tar cigarette. Then the three statements shown in 

Table 4 were read twice, and respondents were asked to decide which of these 

came closest to their opinion. Primacy and recency effects were controlled 

by rotating the order of the first and third statements. The first answer is the 

correct choice, whereas the second answer suggests some reluctance to rely 

on the absolute numerical values when thinking about such tradeoffs. 

The general conclusion to be drawn from these data is that at least onequarter of smokers (i.e., those selecting the third interpretation) clearly have 

been misled about the meaning of the tar yield numbers. Interestingly, this 

increases to 44 percent for smokers of very-low-tar cigarettes, in line with 

other evidence presented here; it also increases concern about the safety 

reassurances that such very-low-tar cigarettes appear to provide. 

131 
Smoking and Tobacco Control Monograph No. 7 

Table 4 

inferences (percent) about tradeoffs between tar deliveries and number of cigarettes smoked 

Tar Levels (mg) 

Very

Low Low Medium High Cannot 

Inference (relative to a 10-rng tar cigarette) 1-5 6-10 11-15 16+ Determine 

Person Probably Could Smoke More Than One, 

but These Numbers Cannot Tell You How 

Much Less Tar the Person Would Take in 

From the 1 -mgTar Cigarette 28 33 31 40 39 

Person Could Smoke More Than 1 or 2 but Less 

Than 9 or 10 of the 1 -mg Tar Cigarettes Without 

Taking in More Tar 18 33 22 25 22 

Person Could Smoke About 10 of the 1 -mg Tar 

Cigarettes Without Taking in More Tar 44 25 31 21 21 

None of These/Do Not Know 10 10 16 14 18 

SMOKERS’USE The final issue under study in this survey was whether smokers 

OF ADVERTISED reported having used these tar numbers to make judgments about 

TAR NUMBERS the relative safety of different brands of cigarettes. In answering 

this question, only 14 percent of the sample indicated doing so. Once again, 

the smokers of 1-to 5-mg tar cigarettes were different: 56 percent of them 

reported using advertised tar numbers to make judgments about the relative 

safety of various cigarettes. 

CONCLUSIONS This study demonstrates inherent difficulties in using advertised tar 

yield numbers to communicate meaningful information to consumers. 

Most smokers do not seem to pay careful attention to the numerical values 

per se, even to the extent of having a strong sense of the range of numerical 

values. Smokers of cigarettes with low- to high-tar content had considerable 

uncertainty about the health implications of switching to lower tar cigarettes. 

However, very-low-tar numbers seem to have a strong appeal to a particular 

group of smokers and may convey a message of absolute safety. 

QUESTION-AND-ANSWERSESSION 

DR. TOWNSEND: Dr. Cohen, can you tell me if you also asked the subjects 

the category of cigarettes that they smoked; for example, was it regular or 

lights or ultralights? 

DR. COHEN: We did not ask them their perception of their cigarette. We 

asked them exactly what they smoked in terms of the size and whether their 

cigarettes were menthol or plain and hard pack or soft pack-but we did not 

ask them their perception. 

132 
Chapter 9 

DR. TOWNSEND: I am not speaking about their perception. I am speaking 

about the advertising associated with the cigarettes that smokers purchase. 

For example, if you go into a store to buy cigarettes, you can buy Winston 

regulars, Winston Lights, or Winston Ultra Lights. And of course, those 

relative categories are based on FTC tar numbers. So, you did not ask them 

a question like that? 

DR. COHEN: No, we didn’t ask that specific question. 

DR. TOWNSEND: My experience, in talking with a lot of consumers, is that 

they do know, very clearly, the category of cigarettes that they are smoking, 

even though some of them do not know the accurate numbers of the 

cigarettes that they are smoking. 

DR. COHEN: I would not disagree with you. 

DR. TOWNSEND: And that ranking of categories is based on the FTC 

numbers. So, I think that your conclusion that the numbers are useless, 

I certainly do not agree with. 

I think another example of that is in my recent purchase of a hot water 

heater. I certainly used the energy efficiency ratings in making that choice. 

I cannot tell you today what the energy efficiency rating actually is. 

DR. COHEN: If we are here looking at the utility of the FTC tar numbers 

in advertising, then I think it is fair to ask if people are taking away this 

information. The assertion is made that this information has value to 

people. I am examining that assertion. 

Now, if you are saying, well, it is not the numbers they care about; it is 

the categories, then you can present information that says they are done in 

four categories. 

DR. TOWNSEND: In addition to that, you also said that there is at least one 

category where a high percentage of those smokers do look at those numbers 

very carefully. So, I think your conclusion that the FTC numbers are useless 

is certainly not true. 

DR. COHEN: I do not know that I went that far; I stopped a little short of 

that. 

DR. TOWNSEND: And I think another very practical example of the utility 

of the FTC relative numbers is, in fact, what has happened to the industry 

over the past 40 years. We have reduced the level of tar delivery, by the 

FTC method, from about 38 mg down to about 12 mg. I think Dr. Hoffmann 

spoke to that very clearly. 

What has happened to cause that dramatic a change is that people trade 

off taste. The lower tar cigarettes generally have-or always have-fewer 

taste characteristics. And people find that more acceptable. So, they are 

making this tradeoff in the marketplace of taste and something else. 

133 
Smoking and Tobacco Control Monograph No. 7 

DR. COHEN: I appreciate your position, though I think we are talking about 

different issues here. I am talking about the utility of this information 

presented in this form as numbers. I am not talking about the utility of 

providing information about tar. 

MS. WILKENFELD: I do want to add one thing to the mix to make it more 

complicated. You said they had to tell you the name of the cigarette they 

were smoking. And in order to get the actual tar number, they would have 

had to report specifically about the category, for example, Marlboro and 

Marlboro Lights. So, they may have reported correctly. 

DR. KOZLOWSKI: I have found out that a lot of people in the United States 

who do not smoke somehow have the impression that tar and nicotine 

ratings are printed on the packs of cigarettes. They are in some places, for 

example, in Canada, but not in the United States. I think the one notable 

exception is the ultralow-tar cigarettes. You know, when you test Carlton 

as low as 1mg tar, they are right on the pack. 

If it is not on packs, if a brand is not advertised, or a person does not see 

an ad, how in the world would they know what the tar and nicotine yields 

were? 

DR. COHEN: I think there is a fundamental problem. I do not think the scale 

has integrity. We had a scale that goes from 1to 27. People don’t care about 

tar; they don’t know what it is. They care about harmfulness; they care about 

smoking risk. 

If you don’t present information to people along a dimension that they 

care about, they are not going to pay as much attention to it. And if you 

don’t present information to people in a way so that they know how to 

use it, where the numbers have some meaningful quality, they will not pay 

attention to it. Then people are not going to be able to do as much with it. 

I think there is a fundamental problem with providing information. 

It may be the wrong information presented the wrong way. Other than 

that, it is OK. 

REERENCE 

Centers for Disease Control and Prevention. Cigarette 

smoking among adults-United States, 1992, and 

changes in the definition of current cigarette 

smoking. MMWR. Morbidity and Mortality Weekly 

Report 43(19): 342-346, 1994. 

134 
Chapter 10 

Sensitivity ofthe Federal Trade Commission 

Test Method to Analytical Parameters 

Michael R. Guerin 

INTRODUCTION The Federal Trade Commission (FTC) test method for determining 

the tar, nicotine, and carbon monoxide yields of commercial cigarettes 

was designed to characterize and compare brands. Relevance to human 

smoking was a consideration in choosing the test method, but the principal 

objective was to select a method that provided the most accurate and 

reproducible result. Relevance to human smoking was addressed by using 

intermittent puffing and by choosing puff volume, puff duration, puff 

frequency, and butt length based on observations of human smokers. 

Accuracy and reproducibility were addressed by selecting a single set of . smoking conditions, demanding narrow tolerances for variation in the 

conditions, and standardizing everything from cigarette selection, to the 

smoking environment, to the laboratory analytical chemical methods. 

Requirements associated with producing a standard method tend to 

conflict with those associated with maximizing relevance to the human 

situation. Bradford and colleagues (1936) recognized from the beginning 

that humans smoke cigarettes in different and varying ways, but a 

standardized procedure requires that variables be set and controlled. 

For practical purposes, only one set of conditions could be selected. 

At least two factors have led to an increased concern about the relevance 

of the FTC test procedure. First, FTC results increasingly have been viewed 

as a measure of human exposure and therefore health risk. The problem 

is compounded by the assumption that even a small difference in FTC 

results signifies a meaningful difference in human exposure. Second, a much 

greater variety of cigarettes is available today. They range from nonfilter and 

filter cigarettes similar to those available when the method was adopted, to 

increasingly popular products with very low FTC yields. Behavioral research 

has demonstrated that low-yield products are consistently smoked differently 

than are higher yield products (Kozlowski et al., 1989). 

This chapter reviews the nature of the FTC test procedure and the 

influence of changes in its specifications on yields. Smoking parameters 

likely to be different for humans from FTC machine smoking are emphasized. 

STANDARD The quantities of tar, nicotine, carbon monoxide, and other constituents 

MACHINE in cigarette smoke are measured using smoking machines. One or more 

SMOKING cigarettes are smoked by a machine, the constituents of interest are collected 

in a suitable trap, and the contents of the trap are chemically analyzed. 

The quantity in the trap is divided by the number of cigarettes smoked to 

compute a yield (or delivery) per cigarette. In the case of the FTC procedure, 

135 
Smoking and Tobacco Control Monograph No. 7 

the particle phase of the smoke is collected on glass fiber (Cambridge) filters, 

and the gas phase (passing through the filter) is collected in gas sampling 

bags. Carbon monoxide is measured in the gas sampling bags. The filter is 

weighed to yield a measure of total particulate matter (TPM) and is analyzed 

for nicotine and water content. Tar (or nicotine-free dry particulate matter) 

is computed by subtracting the weights of nicotine and water from the 

weight of TPM. 

The principal reason for using smoking machines is to maximize the 

reproducibility of results (DeBardeleben et al., 1991). This is particularly 

important for quality control and product comparison and is essential for 

interlaboratory comparisons. However, machine smoking is limited in that 

it provides results accurate only for the specific set of smoking conditions 

employed by the machine. 

Smoking parameters used in the FTC procedure are based largely on 

empirical observations of smokers reported by Bradford and colleagues 

(1936). They suggested a nominal 35-mL (“mL” is used interchangeably in 

the literature with “cc”) puff volume of a 2-second duration taken once per 

minute to a 23-mm butt length. Current FTC smoking conditions (Federal 

Trade Commission, 1994) specify a puff volume of 35 2 0.5 mL, a puff 

duration of 2.0 2 0.2 seconds, and a puff frequency of 1per 60 2 1second. 

Butt length is specified as 23 mm for nonfilter cigarettes and the length of 

filter overwrap plus 3 mm for filtered cigarettes. The international standard 

method (Thomsen, 1992) IS0 3308 currently uses the same conditions but 

requires more stringent tolerances. Puff volume is 35 2 0.25 mL, puff 

duration is 2.0 2 0.05 second, and puff frequency is 1per 60 2 0.5 second. 

Machine-smoking parameters are only one of several conditions that 

have been specified to constitute standard FTC testing. Other conditions 

include the number and manner of selection of cigarettes to be tested, 

cigarette conditioning (see below), the smoking environment, and the 

methods and instrumentation used. FTC testing specifies the analysis of 

100 cigarettes selected at random from two packages purchased at each of 

50 geographical locations throughout the United States. Cigarettes must be 

conditioned at 60 percent relative humidity and 24 “C for at least 48 hours 

before smoking and must be smoked in a room maintained under the same 

conditions. Smoking is performed using a Phipps and Bird 20-port linear 

smoking machine, thus specifying by default that “restricted” rather than 

“free” (butt end closed rather than open to the atmosphere between puffs) 

smoking be performed. Finally, the air flow across the cigarettes must be 

reproducible and controlled to control the rate at which the cigarette burns 

between puffs. 

The introduction of cigarettes with ventilated filters has made it 

necessary to pay additional attention to the depth to which the cigarette is 

inserted into the holder. The cigarette must be inserted sufficiently deep to 

hold it firmly for the smoking process but not so deep as to occlude the 

ventilation holes. 

136 
Chapter 10 

Standardization has produced a remarkably reproducible procedure 

given that the process involves the combustion of highly processed and 

packaged plant material. This is illustrated by the data shown in Table 1. 

Individual laboratories typically generate results with a precision of 

25 percent (relative standard deviation) or better for tar, nicotine, and 

carbon monoxide yields of high-tar products. Interlaboratory agreement 

is generally within 4 and 8 percent of the mean, depending on the 

constituents and number of cigarettes considered. Precision and 

interlaboratory agreement as a percentage of the mean are poorer for 

very-low-delivery (eg, 1 mg tar) products, but the absolute error is similar. 

The procedure is sufficiently reproducible to allow rounding of FTC results 

for tar and carbon monoxide to the nearest whole milligram based on a 

difference between brands of only 0.1 mg (0.4 mg or less reported as <1 mg 

or below detection limit of the method, 0.5 mg or more rounded up to 1mg, 

1.04 mg rounded down to 1mg, etc.). Results for nicotine are rounded to 

the nearest tenth mg. Those with 0.05 mg or greater are rounded up, 

whereas those with 0.04 mg or less are rounded down, as above. 

INFLUENCE Each parameter specified in the FTC testing procedure influences 

OF SMOKING the yields of tar, nicotine, and carbon monoxide. Restrictive 

PARAMETERS tolerances specified for acceptable puff volume, puff duration, and 

so forth are required to allow comparison of similar products and to allow 

interlaboratory comparability. Parameters such as cigarette conditioning 

prior to smoking are specified to accommodate the realities of laboratory 

measurements: in this case, that the cigarettes are likely to be analyzed after 

long periods of cold storage. Minor variations in any of these parameters can 

result in detectable differences in yields. Realistic (comparable with human 

smoking practices) variations also can result in large differences in yields. 

Darrall (1988) has reported a systematic study of the influence of smoking 

parameters on yields of tar, nicotine, and carbon monoxide. Puff durations 

of 1.6 seconds and 2.3 seconds produced essentially the same yields for verylow-tar ($4 mg) cigarettes and almost indistinguishable yields for higher tar 

products (Table 2). No clear trend toward increasing or decreasing yields 

was noted. Changing puff volume from 35 to 40 mL produced a small but 

generally consistent increase in tar and nicotine (Table 3). Low-tar products 

yielded 1 to 3 mg more tar and 0.1 to 0.3 mg more nicotine at 40-mL puff 

volumes than at 35-mL puff volumes. Higher tar products increased yield 

by 2 to 5 mg of tar and 0.1 to 0.5 mg of nicotine. The increases, although 

small, still may be larger than would be found using the standard FTC 

method because the investigator in Darrall’s study (1988) smoked at 2 puffs 

per minute, thus increasing the number of puffs per cigarette. Larger changes 

in puff volume produce larger changes in yields. Browne and colleagues 

(1980) reported that particulate matter yield increased from 29 mg to 55 mg 

for a U.S. blend experimental cigarette when the puff volume was changed 

from 17.5 mL to 50 mL under otherwise standard conditions. Carbon 

monoxide yields were 9 mg and 20 mg for puff volumes of 17.5 mL and 

50 mL, respectively. 

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Table 2 

Influence of puff duration on machine yields 

Yield (mglcigarette)” 

Tar Nicotine Carbon Monoxide 

Brand 1.6 2.3 1.6 2.3 1.6 2.3 

(FTC tar) Seconds Seconds Seconds Seconds Seconds Seconds 

B (1 mg) 2 2 0.3 0.3 1 1 

D (4 mg) 8 7 0.8 0.7 10 8 

E (6 mg) 12 10 0.8 0.8 15 12 

G (9 mg) 15 14 1.4 1.3 15 12 

K (13 mg) 23 22 2.1 2.1 19 17 

T (15 mg) 25 27 2.2 2.4 27 24 

x (25 m9) 38 39 3.6 3.7 22 20 

a 35-mLpuff,30-second interval. 

Source: Darrall. 1988. 

Table 3 

Influence of puff volume on machine yields 

~~~ 

Yield (mg/cigarette)a 

Tar Nicotine Carbon Monoxide 

Brand (FTC tar) 35mL 40mL 35mL 40mL 35mL 40mL 

(B) KS-UM-V (1 mg) 2 3 0.3 0.4 1 1 

(D) KS-EM-V (4 mg) 7 10 0.7 1.0 8 11 

(G) KS-V (9 mg) 14 16 1.3 1.7 12 15 

(H) Regular-V (12 mg) 21 21 0.9 1.0 25 25 

(K) KS-V (13 mg) 22 24 2.1 2.2 17 17 

(0)KS-NV (14 mg) 22 24 2.0 2.3 21 22 

(P) KS-NV (14 mg) 24 28 1.6 2.4 18 24 

ON) Regular-NF (16 mg) 27 26 2.1 2.4 16 14 

(X) Regular-NF (25 mg) 39 44 3.7 4.2 20 21 

a 2.3-second duration, 30-second frequency. 

Key: KS = king size; UM = ultramild (< 4 mg tar); V = ventilated;EM = extra mild (4 to 7 mg tar); NV = nonventilated; 

NF = nonfilter. 

Source: Darrall, 1988. 

139 
Smoking and Tobacco Control Monograph No. 7 

Puff frequency (Table 4) and filter ventilation (Table 5) were found to 

have the greatest effect on yields. Decreasing the puff interval from 60 to 

40 seconds increased the deliveries of tar, nicotine, and carbon monoxide by 

20 to 50 percent on a per-cigarette basis. Using a puff interval of 30 seconds 

increased deliveries by 40 to 90 percent. Blocking the ventilation system of 

ventilated filter cigarettes has similar effects for products using a low degree 

of ventilation and a much greater effect for highly ventilated products. This 

is particularly important for very-low-delivery (e.g., s1 mg tar) products 

because they typically use highly ventilated filters. Darrall (1988) reported 

that complete blockage of the filter ventilation of a nominally 4.0-mg tar 

product resulted in a tar yield of 10 mg (Table 5); nicotine increased from 

0.5 to 0.8 mg, and carbon monoxide rose from 4 to 13mg. Lower yield 

products employ more highly ventilated filters than in Darrall’s (1988) 

example, and the influence of filter blockage would be expected to be 

greater for such products. 

The importance of filter ventilation to FTC testing is illustrated by the 

results summarized in Figure 1. Nonfilter, filter (F), and ventilated filter (VF) 

commercial cigarettes were smoked (see next section, “Influence of Human 

Smoking Practices”) under standard FTC conditions and again under standard 

conditions but with 23 mm of the butt end taped (FTC+). All cigarettes, 

Table 4 

influence of puff frequency on machine yields 

Percentage Increase Over Standard Federal Trade Commission Method 

40 Seconds 30 Seconds 

Carbon Carbon 

Puffs Tar Nicotine Monoxide Puffs Tar Nicotine Monoxide 

Regular (M-H) 28 31 29 26 62 60 49 38 

Regular (M-H) 24 33 32 23 52 69 54 42 

KS-UM-V (L) 47 55 24 43 90 154 47 67 

KS-EM-V (L) 27 31 32 32 52 94 60 64 

KS-EM-V (L) 30 21 19 27 69 84 48 79 

KS (L) 38 19 19 24 76 54 38 43 

KS-NV (L-M) 31 44 35 33 57 62 61 39 

KS-NV (M) 26 26 16 16 60 60 32 32 

IS-NV (L-M) 38 46 42 39 70 62 58 46 

Key: M-H = middle to high tar (23 to 28 mg); KS = king size; UM = ultramild (c4 mg tar); V = ventilated; L = low tar (0 to 

10 mg); EM = extra mild (4 to 7 mg tar); NV = nonventilated; L-M = low to middle tar (1 1 to 16 mg); M = middle tar 

(17 to 22 mg); IS = international size. 

Source: Darrall. 1988. 

140 
Chapter 10 

Table 5 

Influence of ventilation on machine yields 

Yield per Cigarette (mg) 

Percent Blockage 

Brand 

(ventilation) Constituents 0 50 100 

A (55%) Tar 3.8 5.9 10.0 

Nicotine 0.46 0.55 0.82 

Carbon monoxide 3.8 6.0 12.7 

B (35%) Tar 9.2 10.6 12.8 

Nicotine 0.90 0.90 0.98 

Carbon monoxide 9.2 10.9 15.2 

Source: Darrall. 1988. 

including nonfilter, were taped. Nonfilter cigarettes and filter cigarettes 

with little or no ventilation were seen to be only slightly affected by the 

tape. Some effect would be expected for nonfilter cigarettes because taping 

blocks air flow through the cigarette paper, but the changes observed were 

barely statistically significant for the experimental design used. The effect 

on ventilated filter cigarettes (VF-A to VF-F in Figure 1) was significant and 

major. Products rated as FTC 1mg tar yielded 5 mg or more of tar when 

the ventilation was completely occluded. Products rated at 2 to 4 mg of 

tar delivered up to 10 mg of tar. In the case of brand F-F, the substantial 

increase in delivery when cigarettes were taped suggested that the filter 

incorporated ventilation even though it was not obvious from visual 

inspection. Trends for nicotine and carbon monoxide yields were generally 

parallel to those for tar. 

INFLUENCE OF Standardized machine smoking was developed to ensure that 

HUMAN SMOKING differences in yields among cigarettes were caused by the nature 

PRACTICES of the cigarettes and not by differences in the measurement 

method. The FTC adopted standardized machine smoking to maximize 

its ability to discriminate accurately among brands. The FTC test has been 

successful for this purpose but is accurate only where cigarettes are smoked 

as prescribed by the method. 

The relevance of the FTC test parameters to human smoking practices 

has been called into question as FTC ratings have increasingly been viewed 

as a measure of human exposure. This concern is heightened by the 

increasing popularity of low-tar and ultralow-tar products relying largely 

on filter ventilation and by a better understanding of compensatory smoking 

practices. Observation of more recent smoking practice showed that filter 

ventilation was commonly compromised, puff volume was somewhat greater 

141 
Smoking and Tobacco Control Monograph No. 7 

Figure 1 

Tar yields using standard (FTC) smoking conditions and FTC smoking conditions 

with tips taped (FTC+) ' 

30 I 

Cigarette Brand 

Key: NF = nonfilter; F = filter; VF = ventilated filter. 

Source: Jenkins et a/.. 1982. 

than the standard 35 mL, and a puff frequency of 2 to 3 per minute was more 

common than was 1per minute (U.S. Department of Health and Human 

Services, 1988). 

Jenkins and colleagues (1982) surveyed the influence of major changes 

in smoking parameters on the yields of tar, nicotine, and carbon monoxide 

by commercial cigarettes. Results are given in Tables 6 through 8. 

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Smoking parameters were chosen to represent less intense smoking (17-mL, 

1-second puffs, once per minute), conditions considered to be “average” 

smoking (45-mL, 2-second puffs, twice per minute) at the time, and extreme 

(“high”) smoking (75-mL, 3-second puffs, three times per minute) conditions. 

These results were compared with results generated using the standard FTC 

conditions, FTC conditions with 23 mm of the butt end of each cigarette 

taped to completely occlude tip ventilation (FTC+),and the extreme 

conditions with the tips taped (high+). Yields under high+ conditions 

were viewed as the maximum practical yields of the cigarettes. 

The cigarettes chosen for analysis were selected by weight and pressure 

drop (the differential pressure from end to end when air is drawn through a 

cigarette at a rate of 1,050mL per minute [equivalent to a 35-mL puff taken 

over a 2-second period]) from two cartons purchased locally; they were 

conditioned and smoked under FTC-specified environmental conditions. 

The smoke was trapped and analyzed using FTC methods except that carbon 

monoxide was determined using gas chromatography (Horton and Guerin, 

1974) rather than nondispersive infrared spectroscopy. A single-port and 

a linear four-port Filimatic smoking machine were used rather than the 

standard 20-port machine, and one to six cigarettes were smoked per port 

depending on the smoking conditions used. At least four ports of cigarettes 

were smoked per brand or condition, but the precision of the results remained 

2 to 3 times poorer than would be expected using the standard 20-port 

protocol. 

Results for tar deliveries are diagramed in Figure 2. Results for nicotine 

and carbon monoxide generally parallel those for tar (although carbon 

monoxide yields are more scattered and less systematically varied). Several 

observations are apparent. First, the trend toward decreasing yields generally 

parallels the decrease in FTC yields regardless of the conditions used for most 

products. Second, products with barely detectable yields of tar measured by 

the FTC method produce readily detectable quantities of tar when smoked 

under reasonable conditions. Third, even the lowest FTC tar products can 

yield 10 to 20 mg of tar under sufficiently aggressive smoking conditions. 

Products with very low FTC tar yields that depend largely on filter ventilation 

are those most subject to underestimation of practical yields by the FTC 

method. 

Several investigators have reported on the influence of more relevant 

combinations of smoking conditions on the yields of tar and nicotine. 

Table 9 summarizes some of these observations for tar. Rickert and colleagues 

(1983) reported that increasing the puff volume to 48 mL and decreasing 

the puff interval to 44 seconds resulted in an increase of approximately 

40 to 90 percent in the yield of tar over that found using standard FTC 

conditions. Using the same conditions but also occluding 50 percent of the 

filter ventilation resulted in an increase of from 70 to 500 percent depending 

on the product. Percentage increase in yield tended to correlate inversely 

with yield of FTC tar; that is, the lower the FTC yield, the greater the 

percentage increase. 

146 
20 

Chapter 10 

Figure 2 

Influence of smoking parameters on constituent yield 

0 LOW 

Frc 0 Frc+ 

0 Average 

0

+ High High+ 

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Key: low = 17-mL puff volume, 1-second duration, 1 puff/minute; FTC = 35-mL puff volume, 2-second duration, 1 puff, 

minute; FTC+ = same as FTC plus butt end taped; average = 45-mL puff volume, 2-second duration, 2 puffs/ 

minute; high = 75-mL puff volume, 3-second duration, 3 puffs/minute; high+ = same as high plus butt end taped; 

NF = nonfilter; F = finer; VF = ventilated filter. 

Source: Jenkins et al., 1982. 

The Rickert and colleagues (1983), Darrall (1988), and Jenkins and 

colleagues (1982) studies all considered the effect of increasing the puff 

frequency from one per minute to two per minute. Puff volumes varied 

from 40 to 48 mL across the studies, but the results were similar. Smoking 

at two puffs per minute approximately doubled the tar yield for most 

products tested. 

Filter ventilation also has been considered. The Jenkins and colleagues 

(1982) data illustrated that 100 percent ventilation blockage increased the 

tar delivery by a factor of 10 to 20 for very low (c1mg) FTC tar products 

if all other smoking parameters were kept constant. Kozlowski and 

coworkers (1982) reported increases of a factor of 20 to 40 using conditions 

of 100 percent blockage, a 47-mL puff volume, and a 44-second puff interval 

for products rated as <1mg FTC tar. The influence of ventilation blockage 

was smaller but still important for products rated as 1to 6 mg FTC tar (2 to 

6 times increased delivery compared with that measured using the FTC 

method without ventilation blockage), was readily detectable for products 

147 
mlI I yc\i 11-0 
Chapter 10 

rated up to 10 mg FTC tar, and became insignificant for products rated as 

15 mg FTC tar and higher. It is conceivable that a higher tar (e.g., > 10 mg) 

product exists that incorporates a highly ventilated filter. Such a product 

would be affected by ventilation blockage similar to the way lower tar 

products are affected. 

CONCLUSIONS The FTC procedure for measuring the tar, nicotine, and carbon 

monoxide yields of cigarettes provides an accurate measure of yield for 

cigarettes smoked in the specified manner. It serves the purpose of comparing 

the yields of brands smoked under the same (specified) conditions. The utility 

of the procedure for measuring human exposure is doubtful because it is 

unlikely that all brands are smoked in the same way. This is especially the 

case given the wide variety of products currently available. Results using 

realistic combinations of puff volume, puff frequency, and filter ventilation 

blockage suggest that human smoking conditions can produce from two times 

(nonfilter and standard filter brands) to ten times (low-tar and very-low-tar 

ventilated filter brands) the yields of tar that are measured by the FTC test. 

Nicotine and carbon monoxide yields vary similarly. 

The current FTC test procedure must continue to be used if there is a need 

to compare current products with those of the past. New or additional sets of 

smoking parameters must be adopted if a more accurate measure of human 

exposure is desired. 

QUESTION-AND-ANSWER SESSION 

DR. RICKERT There was a question I had asked earlier today and I wonder if 

you could answer it. It looks as though you have some information about 

interlaboratory variation, plus within-lab variation, plus variation over time. 

If you measure, for example, a 12-mg cigarette-how different would another 

brand have to be before you would be comfortable in calling it truly different? 

DR. GUERIN: Certainly it would have to be more than 10 percent different. I 

think that it is more like, at that range, about 2 mg different. 

DR. RICKERT: So, you would say that, for example, 10 mg would be 

considered different from one that was 14; but other than that, there would 

be virtually no difference. 

DR. GUERIN: Right. 

REERENCES 

Bradford, J.A., Harlan, W.R., Hanmer, H.R. Nature of DeBardeleben, M.Z., Wickham, J.E., Kuhn, W.F. The 

cigaret smoke. Technic ofexperimental smoking. determination of tar and nicotine in cigarette 

Industrial and Engineering Chemishy 28(7): 836-839, smoke from an historical perspective. Recent 

1936. Advances in Tobacco Science 17: 115-149, 1991. 

Browne, C.L., Keith, C.H., Allen, R.E. The effect of Federal Trade Commission. “Tar, Nicotine, and 

filter ventilation on the yield and composition of Carbon Monoxide of the Smoke of 933 Varieties of 

mainstream and sidestream smokes. Beitrage zur Domestic Cigarettes.” Internal report prepared for 

Tabakforschung International 10: 81-90, 1980. the National Cancer Institute. Washington, DC: 

Darrall, K.G. Smoking machine parameters and Federal Trade Commission, 1994. 

cigarette smoke yields. Science of the Total 

Environment 74: 263-278, 1988. 

149 
Horton, A.D., Guerin, M.R. Gas-solid 

chromatographic determination of carbon 

monoxide and carbon dioxide in cigarette smoke. 

Journal - Association of Official Analytkal Chemists 

57: 1-7, 1974. 

Jenkins, R.A., Pair, D.D., Guerin, M.R. “Deliveries of 

Tar, Nicotine, and Carbon Monoxide of Selected 

U.S. Commercial Cigarettes Smoked Under ‘More 

Relevant’ Smoking Parameters.” Oak Ridge 

National Laboratory (ORNL) Project Topical Report 

No. 120. Unpublished report, available from the 

authors. Oak Ridge, TN, 1982, 13 pp. 

Kozlowski, L.T., Heatherton, T.F., Frecker, R.C., Nolte, 

H.E. Self-selected blocking of vents on low-yield 

cigarettes. Pharmacology, Biochemistry and Behavior 

33(4): 815-819, 1989. 

Kozlowski, L.T., Rickert, W.S., Pope, M.A., Robinson, 

J.C., Frecker, R.C. Estimating the yield to smokers 

of tar, nicotine, and carbon monoxide for the 

“lowest yield” ventilated filter cigarettes. British 

Journal ofAddiction 77: 159-165, 1982. 

Smoking and Tobacco Control Monograph No. 7 

Rickert, W.S., Robinson, J.C., Young, J.C., Collishaw, 

N.E., Bray, D.F. A comparison of the yields of tar, 

nicotine, and carbon monoxide of 36 brands of 

Canadian cigarettes tested under three conditions. 

Preventive Medicine 12: 682-694, 1983. 

Thomsen, H.V. International reference method for the 

smoking of cigarettes. Recent Advances in Tobacco 

Science 18: 69-94, 1992. 

U.S. Department of Health and Human Services. The 

Health Consequences of Smoking: Nicotine Addiction: 

A Report of the Surgeon General, 1988. DHHS 

Publication No. (CDC) 88-8406. Rockville, MD: U.S. 

Department of Health and Human Services, Public 

Health Service, Centers for Disease Control, Center 

for Health Promotion and Education, Office on 

Smoking and Health, 1988. 

ACKNOWLEDGMENTS This is to thank Ms. Andi Palausky of our group for the 

graphic summaries of data from the Jenkins and colleagues (1982) study. 

This work was sponsored by the National Cancer Institute under Interagency 

Agreement DOE No. 0485-FO53-Al under U.S. Department of Energy 

contract DE-AC05-840R21400 with Martin Marietta Energy Systems, Inc. 

150 
Human Smoking Patterns 

James P. Zacny and Maxine L. Stitzer 

INTRODUCTION It has been established that human exposure to tobacco smoke 

constituents does not reflect package yield characteristics of cigarettes as 

determined by Federal Trade Commission (FTC) smoking machine methods. 

This chapter describes some reasons for this discrepancy by examining 

features of human smoking behavior and how smoking behavior interacts 

with cigarette yield characteristics. The chapter is divided into four sections. 

The first section describes the topography of cigarette smoking; the second 

identifies the parameters of smoking topography that influence smoke 

exposure; the third shows that human smoking patterns are dynamic rather 

than static; and the fourth draws conclusions about the relevance of the 

FTC methodology to human smoking patterns. 

HOW DO The first behavioral aspect of smoking involves holding the cigarette. 

HUMANS When smoking low-yield cigarettes (nicotine yield < 0.9 mg), smokers 

SMOKE? may knowingly or unknowingly block some or all the filter vents with 

their fingers or lips. Blockage of these vents increases the density of 

mainstream smoke that enters the mouth from the cigarette rod because 

the opportunity for air to be drawn into the smoke stream via the vents is 

reduced. Vent blocking essentially can turn a low-yield cigarette into a highyield cigarette. Over the past 10years, Dr. Lynn Kozlowski has performed 

a series of studies in which cigarette butts were assessed for vent blocking. 

He obtained these butts from public access places such as shopping malls. 

From his butt analyses, he estimated the extent to which smokers in the 

United States engage in vent blocking. In one study (Kozlowski et al., 1988), 

the incidence of partial or complete vent blocking of ultralow-yield cigarettes 

(0.1 to 0.4 mg of nicotine) was 58 percent. In a more recent study, Kozlowski 

and colleagues (1994) collected butts of so-called “light” cigarettes (0.5 to 

0.8 mg of nicotine yield) and found that 53 percent of the butts showed 

evidence of some degree of vent blocking. Vent blocking can be detected by 

looking at the filter stain: Cigarettes that are not vent blocked have a dark 

stain in the middle of the filter toe with a visible white ring surrounding the 

stain (Le., “bulls-eye” pattern); cigarettes that are vent blocked have filter 

stains that encompass to varying degrees not only the middle of the filter 

toe but also the periphery. 

What are other features of smoking behavior? The smoker draws on 

the cigarette, inhales the smoke into the lungs, then exhales. Drawing or 

puffing parameters that can be measured include the size of the puff (puff 

volume), the duration of the puff, and the interval between puffs. Inhalation 

parameters that can be measured include the amount of air that is mixed 

with the smoke as it is inhaled into the lungs (inhalation volume, also 

referred to as inhalation depth), the duration to peak inhalation, and any 

151 
Smoking and Tobacco Control Monograph No. 7 

breath holding that occurs. Exhalation parameters include exhalation 

volume and duration. These smoking parameters can now be measured 

with technologies that have been developed over the past 20 years. Puffing 

parameters can be measured with a plastic flowmeter, which is attached to 

a pressure transducer; this system measures pressure differences between 

two points in the flowmeter as the cigarette is puffed. Respiratory parameters 

can be measured with noninvasive respiratory inductive plethysmography. 

Essentially, the degree of movement of the chest and abdomen after 

calibration procedures is directly proportional to volumes of smoky air 

inhaled and exhaled. Thus, smoking is a complex behavior with a number 

of discrete, measurable elements. 

WHICH HUMAN It is important to identify which specific elements of 

SMOKING BEHAVIORS smoking behavior influence smoke exposure to focus on 

DETERMINE SMOKE relevant parameters of the FTC testing procedures vs. 

EXPOSURE? human smoking comparison. Stitzer, Zacny, and other 

colleagues over the past several years have conducted three studies (Zacny 

et al., 1986 and 1987; Weinhold and Stitzer, 1989) that have examined 

the relative importance of various smoking topography parameters in 

determining smoke exposure. Smoke exposure is measured by determining 

the amount of carbon monoxide (CO) and nicotine absorbed from smoking 

a single cigarette-these parameters are called CO boost and nicotine boost, 

respectively. 

In these studies, smokers were trained to puff and inhale the cigarette in 

a standardized fashion. The procedure of the standardization is simple: The 

computer involved in the measurement of smoking topography parameters 

can be programmed to beep when a specified level of a smoking parameter 

has been reached. The investigator programs the computer to give the 

smoker feedback as to when to (1)stop puffing (this controls puff volume), 

(2) stop inhaling (this controls inhalation volume), and (3) start exhaling 

(this controls breath-hold duration). After practice with this biofeedback 

system, the smoker is able to reproduce a given smoking pattern that 

includes a fixed puff volume, inhalation volume, and breath-hold duration. 

In the first study (Zacny et al., 1986), an ultralow-yield cigarette was 

smoked in this standardized fashion, and the number of vents that were 

blocked was varied. In this way, the effect of vent blocking on smoke 

exposure could be determined, as measured by CO boost. Either no vents 

were blocked with tape, 50 percent of vents were blocked, or 100 percent of 

the vents were blocked. Smokers took eight fixed-volume puffs (60 mL) from 

the cigarette, inhaled to a certain volume (25 percent of vital capacity), 

held the breath for a certain duration (10 seconds), and then exhaled. Any 

differences in CO boost could be attributed to manipulation of vent blocking 

because other smoking topography parameters were controlled. The authors 

found a systematic increase in CO boost as a function of number of vents 

blocked. In a second study, Weinhold and Stitzer (1989) varied the number 

of puffs (from 8 to 16) taken from a cigarette. CO boost again increased in 

a linear fashion as a function of number of puffs taken. In a third study 

152 
Chapter 11 

(Zacny et al., 1987), three parameters were systematically manipulated: 

puff volume (15, 30, 45, and 60 mL), inhalation volume (0, 20, 40, and 

60 percent of vital capacity, respectively), and breath-hold duration (0,4, 8, 

and 16 seconds, respectively). As puff volume increased, the amount of 

nicotine and CO absorbed from a cigarette increased in a systematic fashion. 

However, varying the amount of air mixed with the smoke as it was inhaled 

(inhalation volume) did not affect nicotine or CO boost; exposure was as 

great with a shallow inhalation as with a deep inhalation. Breath-hold 

duration increased CO boost but had no effect on nicotine boost. In 

summary, the smoking topography parameters that appear to have the larger 

effect on smoke exposure are vent blocking of low-yield cigarettes and the 

number and size of puffs taken from any cigarette. 

ARE HUMAN Much literature indicates that human smoking patterns are dynamic 

SMOKING and different from the static FTC smoking method. Puffing parameters 

PA’ITERNS change during the course of smoking a single cigarette. Initially, 

DYNAMIC OR smokers take larger and longer puffs from the cigarette, but as they 

STATIC? smoke down the rod, the puffs get shorter and smaller. Interpuff 

intervals are shortest at the beginning of the cigarette and longest near the 

end of the cigarette. Smokers engage in activities that can have an influence 

on smoking topography. Hatsukami and colleagues (1990) developed a 

portable device that measures number of puffs, interpuff intervals, and puff 

durations and assessed these parameters in a smoker’s natural environment. 

They found that variables, including mood of the smokers (relaxed vs. 

stressed) and activities of the smoker (working vs. socializing), influenced 

smoking topographies. Psychoactive drugs other than tobacco (e.g., 

stimulants, alcohol, opioids) also can influence smoking topographies. 

Several investigators have noted changes in smoking topography as a 

function of alcohol. Keenan and associates (1990) studied smoking 

topography in alcoholic and nonalcoholic smokers: Alcoholic smokers 

took more puffs from their cigarettes than did the nonalcoholic smokers, 

indicating more intensive smoking and suggesting higher exposure levels 

per cigarette. 

Two other examples demonstrate that smoking is a dynamic process. 

In the first example, Fant and associates (1995) studied smoking deprivation. 

The number of cigarettes that subjects were permitted to smoke varied from 

0 to 11 during a 6-hour period. The number of puffs taken was directly 

related to the interval between cigarettes and inversely related to the number 

of cigarettes smoked. In the second example, the authors reviewed studies 

over the past 15 years that examined smoking topography as a function of 

cigarette yield. We included only those studies that assessed the smoking of 

commercially available, as opposed to research, cigarettes. We also arbitrarily 

defined high-yield cigarettes as having nonventilated filters and an FTC 

nicotine yield of 0.8 mg or more and low-yield cigarettes as having ventilated 

filters and an FTC nicotine yield of 0.6 mg or less. Table 1 summarizes the 

seven studies that fit these criteria. A consistent finding in these studies is 

that puff volume and puff number are both larger when low-yield compared 

with high-yield cigarettes were smoked. Overall, it is clear that smoking 

153 
Smoking and Tobacco Control Monograph No. 7 

Table 1 

Studies that assessed smoking topography across different cigarette yields, using commercially 

available cigarettes 

Low-High Puff Volume Puff Number 

Nicotine 

Yield Low High Low High 

Reference Number (mg) Yield Yield pValue Yield Yield pValue 

Bridges et al., 1986 5 VS. 6!ja 0.3-1.1 85.4 52.2 0.05 13.2 10.6 ns 

Woodman et al., 1987 10 0.6-1.4 59.5 43.6 0.05 14.0 12.1 ns 

Zacny and Stitzer, 1988 10 0.1-1.1 64.7 52.4 0.05 11.3 12.9 ns 

Nil and Battig, 1989 15 0.5-0.8 25.7 26.6 ns 17.5 13.7 0.05 

Hofer et al., 1991 36a 0.1-1.2 44.5 36.8 0.05 15.6 11.1 0.05 

Kolonen et al., 1991 10 0.4-0.9 76.9 64.6 0.05 18.7 14.4 ns 

Kolonen et at., 1992 8 0.3-1.0 35.6 29.5 0.05 18.5 12.9 0.05 

Mean 56.0 43.7 15.5 12.5 

Ranae 25.7-85.4 26.6-64.6 11.3-18.7 10.6-14.4 

* Cross-sectional study; the sample size in these studies represents each group of smokers studied within a yield 

category. 

Note: All studies were conducted with filtered, commercial brand cigarettes; low-yield brands were all ventilated and 

ranged in nicotine yield from 0.7to 0.6 mg, and high-yield brands were all unventilated and ranged in nicotine 

yield from 0.8 to 1.4 mg. 

Key: ns = not signifiknt. 

topography is dynamic and changes in response to several factors, including 

yield characteristics of the cigarette. 

DOES THE FIT The FTC machine takes 2-secondf 35-mL puffs every minute until 

METHOD a certain point has been reached along the length of the cigarette (i.e., 

ACCURATELY filter overwrap plus 3 mm). The length of the cigarette plays a large 

REFLECT role in how many puffs are taken by the smoking machine, although 

HUMAN porosity of the cigarette paper and tobacco burn rate also play roles. 

SMOKING How does the FTC method of smoking compare with how humans 

PATTERNS? smoke cigarettes? A table in the 1988 Surgeon General’s Report on 

smoking (U.S. Department of Health and Human Services, 1988) summarizes 

results from 32 studies that assessed ad libitum human smoking topography. 

Table 2 lists the average values, along with the range of puffing parameters 

observed in each study. Average puff duration across the 32 studies was 

1.8 seconds, which is fairly close to the smoking machine value. Human 

puff volumes tend to be larger than the 35 mL used in standard FTC smoking 

machine assays. The biggest difference between human and FTC machine 

smoking parameters was in the rate of puffing. The average interpuff interval 

in the human studies was 34 seconds, whereas FTC testing used a 60-second 

interval. Thus, humans took puffs at nearly twice the rate of smoking 

154 
ChaDter 11 

Table 2 

Published values of common measures of smoking 

lnterpuff Puff Puff 

Number of Puffs/ Interval Duration Volume 

Reference Subjects Cigarette (seconds) (seconds) (mL) 

Rawbone et al., 1978 12 10 41 1.8 

Rawbone et al., 1978 9 10 35 2.1 43 

Woodman et al., 1986 9 13 18 1.9 49 

Nemeth-Coslett et al., 1986a 8 8 64 1.8 

Nemeth-Coslett et al., 1986b 8 8 47 1.4 

Nil et al., 1986a 132 13 28 2.2 30 

Jarvik et at., 1978 9 10 

Russell et al., 1980 10 11 35 

Ashton et al., 1978 14 24 1.5 

Schulz and Seehofer, 1978 100 11 50 1.4 

Schulz and Seehofer, 1978 218 12 42 1.3 

Henningfield and Griffiths, 1981 8 10 39 1.o 

Stepney, 1981 19 13 38 

Battig et al., 1982 110 13 26 2.1 40 

Epstein et al., 1982 63 13 2.4 21 

Russell et al., 1982 12 15 26 2.3 40 

Gritz et al., 1983 8 9 47 2.2 66 

Ossip-Klein et al., 1983 9 8 1.4 

Ossip-Klein et al., 1983 9 12 1.9 

Guillerm and Radziszewski, 1978 8 12 41 1.9 39 

Gust et al., 1983 8 9 48 1.6 44 

Adams et al., 1983 10 26 1.9 44 

Moody, 1980 51 7 9 26 2.1 44 

Nil et al., 1984 20 15 26 1.6 40 

McBride et al., 1984 9 16 25 2.1 42 

Medici et al., 1985 17 14 19 2.2 43 

Burling et al., 1985 24 12 28 1.7 

Nil et al., 1986b 117 13 22 2.1 42 

Hughes et al., 1986 46 11 1.6 

Bridges et al., 1986 108 11 56 

Puustinen et al., 1986 11 13 22 2.3 44 

Hilding, 1956 27 10 

Mean 11 34 1.8 43 

Range 8-1 6 18-64 1 .O-2.4 21 -66 -

Note: Data were taken from the baseline phase (or placebo treatment) of studies involving an experimental 

manipulation with at least eight subjects. Values are rounded off to the nearest unit and, in some cases, were 

calculated from other variables or estimated from data presented in figures; missing values indicate that the 

variable was not measured or was not presented in the published study. 

Source: U.S. Department of Health and Human Services, 1988. 

155 
Smoking and Tobacco Control Monograph No. 7 

machine rates used in standardized testing. Across the 32 studies, there 

appears to be a large degree of variability in the values (as shown by the 

range of values listed at the bottom of the table) that is not reflected in the 

FTC method. The average number of puffs taken per cigarette by human 

smokers was 11; FTC does not publish the number of puffs taken from a 

cigarette by the machine. Differences in puffing rates suggest that the 

FTC method probably underestimates the number of puffs taken from 

a cigarette by humans. 

It is possible to estimate the number of puffs used to determine FTC 

cigarette yield by having cigarettes machine-smoked in a research laboratory. 

The authors had a low-yield cigarette brand, Now, smoked according to the 

FTC method at the Tobacco and Health Research Institute in Lexington, 

Kentucky. Two hundred cigarettes were smoked; the average number of puffs 

taken per cigarette was 6.8. This same procedure was repeated with a highyield cigarette, Camel, and an average of 8.3 puffs was taken. Thus, the 

machine took more puffs from the high-yield than from the low-yield 

cigarette, which is at odds with the human data presented in Table 1 in 

which the opposite occurs. Therefore, there appears to be a discrepancy 

between the FTC method of smoking and the way humans smoke differentyield cigarettes: Machines tend to puff less smoke from low-yield than from 

high-yield cigarettes, and humans tend to compensate for air dilution by 

puffing more smoke from low-yield than from high-yield cigarettes. Thus, 

humans smoke low-yield cigarettes in a manner that attenuates machinedetermined yield differences. 

SUMMARY In conclusion, we have shown that the number and size of puffs are key 

factors that determine per-cigarette smoke exposure. Vent blocking is 

another important smoking behavior that can occur with low-yield 

cigarettes. Human smoking behavior is dynamic, not static. There is 

between-smoker variability in smoking topography, and there are dynamic 

changes in response to smoking deprivation, cigarette characteristics, other 

drugs, and situational determinants. The evidence suggests that the FTC 

method does not accurately reflect human smoking patterns. The FTC 

method takes smaller, fewer, and more widely spaced puffs than do humans, 

on average. The underestimation of puff volume is exaggerated with lowyield cigarettes because people tend to increase both the size and number of 

puffs drawn from lower, as compared with higher, yield cigarettes, whereas 

smoking machines decrease the number of puffs drawn while holding puff 

size constant. In addition, the FTC method does not take into account the 

important behavior of vent blocking of low-yield cigarettes. Thus, there are 

important differences between FTC and human smoking that result in the 

machines underestimating the amount of smoke drawn by humans from 

low-yield as compared with high-yield cigarettes. 

156 
Chapter 11 

QUESTION-AND-ANSWER SESSION 

DR. HOFFMANN: How did you cover half of the ventilation holes? 

DR. ZACNY: We did not tape half of the cigarette. We put little pieces of 

square tape all the way around it, so that approximately half the holes were 

unblocked. 

DR. HARRIS: Why is it that it is not how big a puff they took once it was in 

their mouths, but how deeply they drag that puff into the lungs? 

DR. STITZER: I think the explanation is that the dose of nicotine that is 

drawn in with the puff is the critical determinant. The amount of air that is 

breathed in along with it, which is what determines the depth., is how much 

additional volume of air was breathed in with the smoke. That does not 

seem to be relevant with nicotine. 

DR. ZACNY: Even with a shallow inhalation, the surface volume of the lungs 

is pretty huge. 

DR. HARRIS: I understand. It is all in that 1.8-second drag on the cigarette. 

DR. STITZER: Yes. 

DR. HARRIS: Once the smoke is in your mouth, then you can jump up and 

down; it does not matter. 

DR. STITZER: No, once it is in your lungs. Once you have made that 

inhalation maneuver, because if you just hold it in your mouth, that was 

the zero inhalation condition. 

DR. HARRIS: So, as long as you inhale it, it does not matter how much air 

goes in with it. 

DR. RICKERT: One important point is that you haven’t looked at tar. Tar 

may react differently. Depth of inhalation and volume of inhalation might 

be more important. Deposition of tar is not nearly as efficient as for watersoluble vapors and gases. In one of the documents that we received from 

the tobacco industry, there is a study that has been cited by Stitzer, which 

says that, on 1,631 cigarette butts, only .1percent were completely blocked. 

The information that you have provided today suggests that it is somewhere 

between 53 and 58 percent. What is the reason for the discrepancy? 

DR. ZACNY: The reason for the discrepancy is that those 1,600 butts are 

from only 10 subjects. We had them smoke the ultralow cigarettes for a 

week and save the butts. We then analyzed the stain patterns. 

We were looking at the acute effects of smoking these ultralow cigarettes 

in the field, and there may be a lower incidence of blocking than what you 

see when Lynn Kozlowski does his cross-sectional studies-when people have 

been normally smoking these cigarettes for a long time. Plus, our data were 

from only 10 subjects. 

157 
Smoking and Tobacco Control Monograph No. 7 

DR. RICKERT: Do you feel that this blocking is something that we should be 

concerned about? 

DR. ZACNY: Yes. 

DR. SHIFFMAN: One of the issues that you raised that we have not discussed 

much is variability within a given smoker, due to brand switching, for 

example. Can you give us some quantitative estimates of the degree of 

variability? 

DR. ZACNY: I believe Dr. Stitzer would be the best person to answer this 

question. 

DR. STITZER: In one example, it was shown for deprivation to be 10 to 

15 puffs. And that makes quite a big difference when you multiply it by the 

puff volumes, leading to a substantial difference in cumulative puff volume. 

DR. HATSUKAMI: Also, one subject after meals typically took about eight 

puffs per cigarette, whereas on the telephone, they would take about five 

puffs from the cigarette. 

DR. TOWNSEND: Dr. Zacny, I am a bit confused about the whole blockage 

question. Is the measure that you used to determine hole blockage just the 

staining at the mouth end of the filter? 

DR. ZACNY: Yes. Different cigarettes have different types of what we call 

tipping and different types of perforations. The perforations differ largely 

in the number of holes and the size of those holes. 

Those parameters of ventilation, in fact, determine to a large degree the 

staining pattern in the first place. So, it is possible to make a highly airdiluted cigarette with many ventilation holes that are very small and, in 

fact, see relatively uniform staining patterns right at the mouth end of the 

cigarette. 

If you are interpreting that as vent blocking, then I think that is probably 

an incorrect conclusion, because of the design of that specific filter. Filters 

with large though very few holes will tend to force the smoke to the center 

of the filter, and you will see that bullet shape right at the mouth end that 

was shown in one of the slides. 

The concern is that not all cigarettes are built in the same way and so 

that it is probably a bit premature to conclude that there is vent blocking 

solely on the basis of filter observation. 

DR. STITZER: The data that were presented in this talk showed what 

happened to smoke exposure when the vents were experimentally blocked 

with tape. Dr. Townsend is asking a different kind of question about 

measurement of blocking in the natural environment. 

DR. TOWNSEND: So, these were not with actual subjects, then? 

DR. STITZER: They were with natural subjects, but we blocked the vents. 

158 
Chapter 11 

DR. ZACNY: You were talking about the first study when we looked at 50 

and 100 percent of hole blocking. 

DR. TOWNSEND: I understand. I would like to talk with you some more 

about this, because we have some data at R.J. Reynolds where we have gone 

directly to an inhydrin staining test where the saliva on the filter, in fact, 

stains with inhydrin; therefore, we can visually see how much saliva has 

gotten up to the vents. 

What we have seen in a study with a number of subjects is that the spent 

butts show some blockage, but it is a very infrequent phenomenon. So, I 

would like to talk to you further about that. Perhaps we can propose doing 

some additional studies. 

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Puustinen, P., Olkkonen, H., Kolonen, S., Tuomisto, J. 

Microcomputer-assisted measurement of inhalation 

parameters during smoking. Archives of Toxicology 

[Suppl9]: 111-114, 1986. 

Rawbone, R.G., Murphy, K., Tate, M.E., Kane, S.J. The 

analysis of smoking parameters: Inhalation and 

absorption of tobacco smoke in studies of human 

smoking behaviour. In: Smoking Behaviour. 

Physiological and Psychological Influences, R.E. 

Thomton (Editor). Edinburgh: Churchill 

Livingstone, 1978, pp. 171-194. 

Russell, M.A.H., Sutton, S.R., Feyerabend, C., Saloojee, 

Y. Smoker's response to shortened cigarettes: Dose 

reduction without dilution of tobacco smoke. 

Clinical Pharmacology and Therapeutics 27(2): 210- 

218,1980. 

Russell, M.A.H., Sutton, S.R., Iyer, R., Feyerabend, C., 

Vesey, C.J. Long-term switching to low-tar lownicotine cigarettes. British journal of Addiction 77(2): 

145-158, 1982. 

Schulz, W., Seehofer, F. Smoking behaviour in 

Germany-the analysis of cigarette butts (KIPA). 

In: Smoking Behaviour. Physiological and Psychological 

Influences, R.E. Thomton (Editor). Edinburgh: 

Churchill Livingstone, 1978, pp. 259-276. 

Stepney, R. Would a medium-nicotine, low-tar 

cigarette be less hazardous to health? British Medical 

Journal 283(6302): 1292-1303, 1981. 

US. Department of Health and Human Services. The 

Health Consequences of Smoking: Nicotine Addiction. 

A Report of the Surgeon General, 1988.DHHS 

Publication No. (CDC) 88-8406. Rockville, MD: 

U.S. Department of Health and Human Services, 

Public Health Service, Centers for Disease Control, 

Center for Health Promotion and Education, Office 

on Smoking and Health, 1988. 

Weinhold, L.L., Stitzer, M.L. Effects of puff number 

and puff spacing on carbon monoxide exposure 

from commercial brand cigarettes. Pharmacology, 

Biochemistry and Behavior 33: 853-858, 1989. 

Woodman, G., Newman, S.P., Pavia, D., Clarke, S.W. 

Inhaled smoke volume, puffing indices and carbon 

monoxide uptake in asymptomatic cigarette 

smokers. Clinical Science 71(4): 421-427, 1986. 

Woodman, G., Newman, S.P., Pavia, D., Clarke, S.W. 

Response and acclimatization of symptomless 

smokers on changing to a low tar, low nicotine 

cigarette. Thorax 42: 336-341, 1987. 

Zacny, J.P., Stitzer, M.L. Cigarette brand-switching: 

Effects on smoke exposure and smoking behavior. 

Journal of Pharmacology and Experimental 

Therapeutics246: 619-627, 1988. 

Zacny, J.P., Stitzer, M.L., Brown, F.J., Griffiths, R.R. 

Human cigarette smoking: Effects of puff and 

inhalational parameters on smoke exposure. Journal 

of Pharmacology and Expm'mental Therapeutics 240: 

554-564, 1987. 

Zacny, J.P., Stitzer, M.L., Yingling, J.E. Cigarette filter 

vent blocking: Effects on smoking topography and 

carbon monoxide exposure. Pharmacology, 

Biochemistry and Behavior 25: 1245-1252,1986. 

160 
Chapter 12 

Compensation for Nicotine by Smokers 

of Lower Yield Cigarettes 

Lynn T. Kozlowski and Janine L. Pillitteri 

BACKGROUND The question has been asked whether brand-switching smokers 

oversmoke lower nicotine cigarettes. The Federal Trade Commission 

(FTC)testing method is a per-cigarette test and should be judged as such. 

(Forty truly low-calorie candy bars together could be high calorie and still, 

individually, be low calorie.) The FTC test cannot be blamed because 

smokers smoke more cigarettes when they switch to those having a lower 

yield. Therefore, for this review compensation data were adjusted to percigarette values. However, such per-cigarette adjustments only approximate 

what would happen if the number of cigarettes were fixed for smokers. 

If smokers have already compensated by smoking many more cigarettes, 

then presumably they would have less need to smoke more of each cigarette. 

In the five studies included in the authors’ main review, the compensatory 

percentage change in cigarettes per day averaged 15 percent (26, 95-percent 

confidence interval). No studies showed a decreased number of cigarettes 

smoked with a lower yield brand of cigarettes. 

Experimental brand-switching studies offering measures of nicotine 

and cotinine were reviewed. An index of compensation was calculated 

using a sequence of formulas developed by Russell and colleagues (1982). 

Calculation of these formulas first requires information on the machinesmoked nicotine yields of cigarettes to calculate (a) the percentage change 

in nicotine yields. Information on the measured level of nicotine (or 

cotinine) in body fluids is then used to calculate (b) the percentage change 

in nicotine (or cotinine) intake. Finally, three consecutive formulas are 

used to calculate (c) the actual compensatory increase in smoke intake 

[(b/a - 1)x 1001; (d) the increase in smoke intake necessary for complete 

compensation [(1- a)/a x 1001; and (e) using the values obtained in (c) and 

(d) above, the degree of compensation [(c/d) - 1001. 

CIGARETTE BRAND Research on brand switching makes use of repeated-measures 

SWITCHING IN designs. With these designs, the same smokers get different 

EXPERIMENTAL cigarettes. This controls for individual differences in drug 

RESEARCH metabolism (Benowitz et al., 1982) and for important biases 

in brand selection, which usually are not controlled for in cross-sectional 

research. This issue has been discussed by others (e.g., Giovino et al. [this 

volume]; Cohen [this volume]). Wynder and coworkers (1984) explored the 

demographics of smokers of the low-yield cigarettes and showed that age, 

sex, race, education, and religion were strongly related to the selection of 

low-tar cigarettes. Wynder and colleagues (1984) reported that education 

is negatively associated with tar for males, but not for females. (Tar and 

161 
Smoking and Tobacco Control Monograph No. 7 

nicotine are highly correlated across the full range of tar and nicotine yields.) 

People who smoke low- and ultralow-yield cigarettes may be more health 

conscious, have better diets, and be interested in smoking less. A random 

sample of persons does not select ultralow-yield cigarettes. 

Despite their advantages, experimental brand-switching studies have 

important limitations. Outside of laboratories, smokers select their own 

brands. There is a free market for most purchases of cigarettes. An 

unsatisfying brand is likely to be rejected for a satisfying brand. Persons 

trying an ultralow-yield cigarette may feel that they are puffing on air, so 

they decide not to smoke these cigarettes and probably will not buy more 

than one pack. Some compensatory smoking techniques (e.g., vent blocking 

[Kozlowski et al., 1980 and 19891) may take time to be learned by trial and 

error. Short-term studies (i.e., less than 1week of exposure on lower yield 

brands) do not provide an adequate indication of the nature of compensatory 

smoking in self-selected smokers. All reviewed studies involved brand 

manipulations (change of “treatment” or brand in experimental study) 

of more than 7 days. 

Studies of brand switching also have biased samples. Who does and 

does not volunteer for these studies? One of the five studies reviewed 

(Guyatt et al., 1989) showed a dramatic number of dropouts following 

informed consent. Of the people who went to at least one session in this 

study, 81 percent dropped out. Another study on brand switching (Benowitz 

et al., 1986a) required that participants be hospitalized for 14 days. Some 

smokers, knowing that they were going to get ultralow-yield cigarettes, 

either might not have wanted to smoke them or spend 14 days in the 

hospital. One must wonder who would be available to participate in a 

14-day study requiring confinement to a hospital room. Most studies of 

brand switching also have small samples (mean = 22 subjects). As for 

demographic differences, there is no way to represent the complexities of 

age, sex, race, and education adequately in a sample of 22 participants. 

According to the boundary model of drug regulation, plasma nicotine 

levels are not precisely regulated (Kozlowski and Herman, 1984); there are 

aversive upper and lower limits or boundaries on intake for dependent 

smokers. At the upper limit, when people are smoking a great deal, it is 

difficult for them to smoke more due to overdose or toxic effects of nicotine. 

When they are smoking a little, it is hard for them to smoke less than the 

lower limit because of insufficient nicotine intake. However, within these 

broad limits or boundaries, psychosocial factors primarily (i.e., the presence 

of others smoking) determine nicotine ingestion, and dose manipulations 

tend to have a smaller effect on smoking behavior (Kozlowski and Herman, 

1984; Kozlowski, 1989) and how smokers feel (Benowitz et al., 1986b). 

RESEARCH Table 1shows the five studies reviewed and gives a summary of their 

results. The following studies were not included in the review because they 

were either too short term or used cigarette holders, which could interfere 

with natural smoking behavior: Benowitz and colleagues (1986a), Kolonen 

162 
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Smokinn and Tobacco Control Monograph No. 7 

and colleagues (1991), Russell and colleagues (1975), and Zacny and Stitzer 

(1988). 

Figure 1 shows the pattern of results across the five studies. The solid 

line summarizes results from the studies after adjusting for changes in the 

number of cigarettes smoked. As nicotine yields go below the usual 

“normal” levels (1.0 to 1.4 mg nicotine), more compensation takes place 

until the lowest yield is reached. At this point, too much work may be 

required of smokers to achieve substantial compensation. This kind of doseresponse pattern is consistent with that for other reinforcers. It may not be 

important to compensate for a 0.9-mg nicotine cigarette; it easily provides 

adequate levels of nicotine. The dashed line shows what happens when 

there is no adjustment for changes in the number of cigarettes smoked. 

This shows that compensation also is supported by an increase in cigarettes 

per day in these brand-switching studies (the 0.4-mgnicotine cigarette now 

shows close to 80 percent compensation). 

Figure 1 

Pattern of results illustrating percentage compensation across the five reviewed studies, 

unadjusted (dashed line) and adjusted (solid line) for number of cigarettes 

100- -0- Unadjusted for number of cigarettes 

Adjusted for number of cigarettes 

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164 
Chapter 12 

The short-term study by Zacny and Stitzer (1988) (not included in our 

review) examined smokers who had been given three different lower yield 

brands (i.e., 0.1 mg, 0.4 mg, 0.7 mg nicotine). This study produced a pattern 

of compensation similar to that in Figure 1. 

For consumers, the average percentage compensation may be less 

important than the likelihood of substantial compensation. If 1in 2, 1in 5, 

1in 10, 1in 50, or even 1in 100 smokers shows compensation of 25, 33, 55, 

or 75 percent, then a problem exists. If automobile brakes failed at a rate of 

even 1in 1,000, this rate would be of great concern to manufacturers, 

consumers, and regulatory agencies. 

ONE REPEATED- Lynch and Benowitz (1987) conducted a self-selected brandMEASURES STUDY switching study of participants who spontaneously switched 

OF SELF-SELECTED cigarette brands. The study included 62 people who had 

BRAND SWITCHING lowered their standard yield. When they had been studied 

earlier, they had had plasma measures taken, and they were recontacted 3 to 

6 years later. In this group, the low-yield cigarette was 62 percent of the 

former usual cigarette yield of nicotine (.68 mg versus 1.09 mg). Plasma 

cotinine per cigarette was unchanged: 10.3 ng per mL for the low-yield 

cigarette versus 10.2 ng per mL for the former usual cigarette. This represents 

a compensation of 103 percent! 

SMOKERS CAN GET Some points should be made about vent blocking and the 

HIGH YIELDS FROM possibility of getting high yields from ultralow-yield brands. 

THE LOWEST OF In one study, 14 people were smoking ultralow-yield cigarettes 

THE LOW-YIELD (Kozlowski et al., 1989), and half the smokers were vent 

CIGARETTES: blockers. Two of the seven vent blockers smoked about 

MORE ON THE 25 cigarettes per day and each blocker showed carbon 

ISSUE OF VENT monoxide scores of 37 parts per million, which are very high. 

BLOCKING Salivary cotinine levels of 303 and 385 ng per mL, from a 

nominally .Ol-mg nicotine cigarette, are also very high. Therefore, there 

were high exposures from a very-low-yield cigarette, clear evidence that some 

smokers-if only two-were able to get substantial levels from the lowest of 

the low-yield cigarettes. 

Some submissions from the cigarette industry have indicated that vent 

blocking is not a substantial problem. In contrast, four laboratories have 

produced eight peer-reviewed studies that found evidence of vent blocking 

(Hofer et al., 1991; Kozlowski et al., 1982a, 1988, 1989, and 1994; Lombard0 

et al., 1983; Robinson et al., 1983; Zacny and Stitzer, 1988). In these studies, 

the prevalence of “extreme” vent blocking ranged from 1to 210 per 1,000 

(median = 19 percent), and the prevalence of “at least some blocking” ranged 

from 61 to 580 per 1,000 (median = 50 percent). 

One submission from the cigarette industry notes that ventilation has 

changed a great deal recently. However, invisible laser ventilation has been 

available for at least a decade. From a consumer’s point of view, it is unclear 

why invisible ventilation techniques should be viewed as appropriate. 

165 
Smoking and Tobacco Control Monograph No. 7 

Smokers can block the vents inadvertently if they do not know where the 

vents are and what they do. If smokers know where the vents are located, 

they can decide to avoid blocking the vents. There are real questions about 

who is most advantaged by laser techniques and invisible perforations. 

Marlboro Lights, Winston Lights, Camel Lights, and Newport Lights 

(“lights” in general) are ventilated-filter cigarettes. Much of the focus of 

research has been on the ultralight cigarettes of 5 mg of tar or less. Unlike 

the ultralights, these light cigarettes are best sellers, but like the ultralights, 

they are ventilated-filter cigarettes. Therefore, the principle of informing the 

consumer that these are ventilated cigarettes, discussing how the vents work, 

and warning about blocking the vents with the fingers or lips is relevant to 

lights as well as ultralights. 

Anyone who is skeptical about vent blocking of ultralow-yield cigarettes 

should take the lowest tar challenge: Light a l-mg tar cigarette, placing your 

lips on the filter as close to the smoker end as possible. Keep your fingers off 

the filter so your fingers do not get in the way (i.e., do not block the vents 

with your fingers) and take a puff. Consider its taste, temperature, and feel. 

Now put your lips at least three-quarters of the way to the tobacco column 

(i.e., block the vents with your lips) and take another puff of similar size. 

(In our butt collection studies [Kozlowski et al., 1988 and 19941, we regularly 

have found lipstick stains beyond the filter vents, on the filter end of the 

cigarette, showing how far the cigarette had been put into the mouth.) 

Co’mpare the second puff to the first. See for yourself how easy it is to block 

the vents and how much difference it makes to real tobacco pleasure by 

doing this. Those onlookers who prefer not to take a puff of cigarette smoke 

can usually see the difference in the smoke that is exhaled by someone else 

because blocked vents produce a “juicy” mouthful of smoke that billows out 

from a noninhaled puff of smoke. With unblocked vents, onlookers will see 

only a little smoke exhaled. 

GRAPHIC In 1982, a study was published on a color-matching technique to 

INFORMATION provide better information on tar and nicotine yields to smokers 

ON TAR AND (Kozlowski et al., 1982b). The color-matching technique can be 

NICOTINE YIELDS: used to estimate the number of puffs taken on a cigarette, and 

THE COLOR- thus tar and nicotine yields, by comparing the color intensity of 

MATCHING the end of a spent cigarette filter with a color scale. The study 

TECHNIQUE demonstrated a strong relationship between the “darkness” of 

color of the filter and the tar and nicotine yield of the cigarette. Figure 2 

illustrates a modified version of the color-matching scale that the authors 

incorporated on a cigarette package. Three different color papers (meant to 

represent tar stains of low, standard, and high yields) developed by the 

authors from the Pantone by Letraset Color-Matching System are used to 

compare the filter stain colors from spent cigarettes. The low (Pantone 

127U), standard (Pantone 117U), and high (Pantone 139U) colors are 

mounted on the scale at points 2, 5, and 8, respectively. Smokers rated the 

filter stain color on the 040-10 scale, moving from the lower to the higher 

intensity color blocks. They decided “whether the filter looked lighter, 

166 
Chapter 12 

Figure 2 

The color-matching technique scale shown on a cigarette package. (Pantonecolored papers representing low, standard, and high yields at scale locations 2,5, 

and 8, respectively.) The appearance of an unblocked vented filter is shown in the 

bull’s-eye stain; the uniform stain on the filter end indicates extreme vent blocking. 

1 I I I I I I I I I I 

0 1 2 3 4 5 6 7 8 9 10 

Low Medium High 

To use scale, filter must look 

Not 

Necessarily 

Lights 

darker, or about the same as each of the colored blocks, and then selected 

the most appropriate scale number” (Kozlowski et al., 1982b). 

Figure 2 also shows how stain patterns on spent filters can be used to 

indicate whether vent blocking has taken place on a conventional ventilated 

filter cigarette (Kozlowski et al., 1980). The bull’s-eye tar stain on the left 

indicates no vent blocking. (Diluting air rather than smoke has been drawn 

through the periphery of the filter.) The uniform tar stain on the right 

indicates extreme vent blocking. On ventilated-filter cigarettes, vent 

blocking decreases filter efficiency so that the amount of stain left in the 

filter underestimates the amount of smoke that has gone through the filter; 

167 
Smoking and Tobacco Control Monograph No. 7 

in other words, the color-matching technique requires the assumption that 

vents remain unblocked. Because vent blocking alters yields dramatically, 

the graphic reminder not to block vents also may be useful in its own right. 

The color-matching technique is a tool that can be used in future studies 

on compensation. Figure 2 also demonstrates how the color-matching 

technique and the stain-pattern technique could be included on cigarette 

packaging for consumer use. Color-matching information may better reflect 

the actual cigarette yields to smokers than the alternative FTC method. The 

FTC machine estimates of tar and nicotine yields can be unreliable given the . 

variability among smokers and the various methods of compensation. 

Further developmental work is needed on this color-matching technique. 

In the land of a largely blind FTC testing method, even a one-eyed colormatching technique could be king (Kozlowski and Rickert, 1984). It is not 

necessary to be perfect in providing the consumer with better information 

about the tar and nicotine yields of cigarettes to improve on the current 

standard method. A color scale attached to cigarettes can emphasize to the 

consumer that the yields from a cigarette depend on how the cigarette is 

smoked. Graphically, a color scale helps smokers see that yields are not 

captured by any one tar or nicotine number, and thus smokers can get a 

sense of where they stand in relation to the standard. 

SUMMARY Our review of brand-switching studies indicated that smokers increase 

nicotine intake from lower yield cigarettes by compensatory behavior, 

including filter-vent blocking. This behavior is a neglected issue for smokers 

of light and ultralight cigarettes. The current FTC testing method used to 

estimate average tar and nicotine yields of cigarettes is compromised by 

compensatory smoking behavior and individual variability among smokers. 

Graphic techniques (e.g., the color-matching technique and the stain-pattern 

technique) also need to be explored as ways to provide estimates of tar and 

nicotine yields to smokers of lower yield cigarettes. Simple graphic materials 

may help these smokers realize that a low-yield cigarette can provide high 

yields when smoked in certain ways. 

QUESTION-AND-ANSWER SESSION 

DR. BENOWITZ: Lynn, you said that in one study about half the people 

were vent blockers. My work and the Gori study suggest that people are 

taking in, on average, about .7 mg of nicotine per cigarette, which is 

tremendously more than would be possible taking more puffs. So, I think 

virtually everyone who smokes ultralow-tar cigarettes must be blocking. 

And how many of the holes do these ultralow-tar cigarette smokers block? 

DR. KOZLOWSKI: The story I like is the student of mine in class who said 

his aunt, who smokes an ultralow-tar cigarette, keeps a roll of transparent 

tape on her coffee table. When offering a cigarette to a friend she will say, 

“Do you want that taped or untaped?” Bizarre as that might be; it happens. 

It illustrates that people do not understand what ventilation does to 

their cigarette. I had a call years ago from an angry executive as a result of 

168 
Chapter 12 

some media exposure about the results of some of these studies. He said, 

“I have a l-mg tar cigarette, and yes, I block the vents on that cigarette, and 

yes, it makes it taste better and it is easier to light, but I thought it was a 

l-mg tar cigarette; it says so right on the pack.” 

Ventilation is not the only manufacturing technique that contributes to 

an ultralow-yield cigarette. There can be other differences that mean that, 

even with blocking, the smoker will not necessarily get the same really high 

levels that you might with some other cigarettes. But it is clear that it is a 

major factor; it is clear that smokers can subvert it completely or even 

partially. 

Lombard0 did a study years ago with people staining their fingers with 

printer’s ink. And he found that, as the cigarette coal burns down, and your 

fingers are getting away from it, they start to get in the way of the vent holes. 

It is also interesting that those last few puffs are the richest, and if you were 

to block those holes, that would be a particularly good time to do that to get 

higher yields. 

DR. TOWNSEND: Dr. Kozlowski, how did you measure the vent blockage? 

DR. KOZLOWSKI: We have done it a few ways. Most of the time it is a stain 

pattern method. 

DR. TOWNSEND: On the mouth end of the filter? 

DR. KOZLOWSKI: Yes. 

DR. TOWNSEND: What I do not understand about something you just said 

is that people will purposefully tape holes closed. I think my experience with 

consumers is that they clearly know the tradeoffs between tar delivery of a 

cigarette and taste characteristics. 

It would really surprise me that consumers would make that purposeful 

change to the design of a cigarette and not understand that they are 

increasing tar. Besides, they have the choice to go out into the market and 

buy a higher tar product if that is what they choose; so I do not understand 

the rationale or the psychology here. 

DR. KOZLOWSKI: I think it is something to be surprised about. 

DR. TOWNSEND: About the compensation issue, there is another answer 

that I do not completely understand. 

Let’s assume that compensation occurs to a very large degree, and people 

get essentially the same deliveries from a low-tar cigarette that they get from 

a higher tar cigarette. Then, why do consumers complain to us that the taste 

of low-tar cigarettes is weaker, milder, less strong, and less acceptable? 

Again, their perception is that tar and taste go together. As a smoker, 

I can fairly accurately estimate the tar yield of a cigarette by smoking it, and 

I can get within a couple of milligrams. 

169 
Smoking and Tobacco Control Monograph No. 7 

I think many smokers, while they may not be as accurate in estimating 

FTC tar yields, still can rank cigarettes by tar. Now, how could they possibly 

do that if compensation were extensive? 

DR. KOZLOWSKI: I think you do not want to think of compensation as 

something that influences everybody’s smoking behavior. What we found 

in the Pharmacology, Biochemistry and Behavior study, half of the people block 

vents quite a lot, and the other half did not block them at all. 

And if you looked further at those who did not block, you found that 

they did not smoke as many cigarettes per day. If you did taste ratings and 

how they liked the taste of the cigarette, they seemed to be consumers who 

were after a really low-yield smoke. They weren’t blocking the holes. Not 

everybody smoking a low-yield cigarette blocks the vents. But this gets back 

to the issue of subject self-selection biases. We have to expect that there are 

individual differences in how much nicotine a person might want and also 

to the extent that a person is smoking for nicotine. 

So, half of those subjects who were smoking ultralow-yield cigarettes 

in the long term were not blocking vent holes; they did not smoke many 

cigarettes per day; and they had low CO levels. The other half smoked 

a lot more cigarettes a day, smoked earlier in the morning, and got higher 

nicotine levels. You average them, and you get the kind of figures that are 

commonly described as “intermediate.” Some people were showing a lot 

of compensation; some were showing very little; and that figure of mean 

compensation can be misleading. 

DR. DEBETHIZY: I think you have pointed out an important fact: No 

machine-smoking method can predict individual behavior. This method 

was never intended to predict individual behavior, and it does not. I think 

people use different strategies when they smoke cigarettes, and it is rather 

obvious in the data you presented today. 

DR. COHEN: Is it your intuition that a great many people who compensate 

are just following classic learning theory and do not even know they are 

doing it? 

DR. KOZLOWSKI: Some people are not aware they are doing it; that is clear. 

They are not aware they are blocking the holes. I think that some people 

find the cigarettes relatively difficult to light. You push it a bit further in 

your mouth and it is a lot easier to light. Blocking could get started in a 

number of ways. 

DR. SHIFFMAN: We have all been struggling with the issue of variability 

within a given product or products of equal FTC yield, I think, in talking 

about compensation and in the difference between the machine yield and 

the human biological exposure. 

Now, with this issue of color matching, you are introducing something 

that I think has to do with true exposure rather than FTC yield. I wonder 

what you could tell us about the prospects of using a system like this to 

170 
ChaPter 12 

estimate exposure, the differences that might be due to things other than 

number of puffs, and all the kinds of things we think a compensating smoker 

might do. 

DR. KOZLOWSKI: I think Dr. Rickert might be able to comment intelligently 

on that. 

DR. RICKERT: One of the things that we have done is to look at the yield of 

a cigarette in relationship to the color of the filter itself. We have established 

that there is an extremely good regression between the measured color 

characteristic of the filter and the FTC yield. We have done that on the 

smoking machine and for the actual filter on cigarettes. We have looked 

at yields under 87 different conditions to cover a wide range of potential 

behavioral conditions. And we have looked at the yields under those 

conditions and have looked at the relationship between that and color. 

And color of the filter is a very good predictor of yields under a wide variety 

of conditions. 

DR. HENNINGFIELD: I would just like to point out that the kinds of 

compensation that you see are consistent with what Dr. Zacny was talking 

about, the dynamic smoker, what I was talking about, the addicted and 

behavior-modified smoker. But it is also very similar to what you see in the 

animal laboratory, with addictive drugs like alcohol, sedatives, and opiates. 

What you see is that as you push the dose up, you get some downward 

compensation. As you decrease the dose, you get some upward. But it is 

within a boundary. It is rarely perfect, because as you increase the dose, the 

animals tend to get a little more drug. If you decrease the dose to a certain 

point, the behavior can kind of just fall apart and get very erratic. It just 

struck me how similar it was, what we see with animals and addictive drugs, 

and what you are seeing. 

DR. KOZLOWSKI: I agree. 

DR. HENNINGFIELD: It looks like a basic biological phenomenon, in other 

words. 

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Kozlowski, L.T., Herman, C.P. The interaction of 

psychosocial and biological determinants of tobacco 

use: More on the boundary model. Journal ofApplied 

Social Psychology 14: 244-256, 1984. 

Kozlowski, L.T., Pillitteri, J.L., Sweeney, C.T. Misuse 

of “light” cigarettes by means of vent blocking. 

Journal of Substance Abuse 6: 333-336, 1994. 

Kozlowski, L.T., Pope, M.A., Lux, J.E. Prevalence of the 

misuse of ultra-low-tar cigarettes by blocking filter 

vents. American Journal of Public Health 78: 694-695, 

1988. 

Kozlowski, L.T., Rickert, W.S. Kozlowski, Rickert reply. 

American Journal ofPublic Health 74: 391, 1984. 

Kozlowski, L.T., Rickert, W.S., Pope, M.A., Robinson, 

J.C. A color-matching technique for monitoring tar/ 

nicotine yields to smokers. American Journal of Public 

Health 72: 597-599, 1982b. 

Kozlowski, L.T., Rickert, W.S., Pope, M.A., Robinson, 

J.C., Frecker, R.C. Estimating the yield to smokers 

of tar, nicotine, and carbon monoxide from the 

“lowest yield” ventilated filter-cigarettes. British 

Journal of Addiction 77(2): 159-165, 1982a. 

Smoking and Tobacco Control Monograph No. 7 

Lombardo, T., Davis, C.J., Prue, D.M. When low tar 

cigarettes yield high tar: Cigarette filter ventilation 

hole blocking and its detection. Addictive Behaviors 

8: 67-69, 1983. 

Lynch, C.J., Benowitz, N.L. Spontaneous cigarette 

brand switching: Consequences for nicotine and 

carbon monoxide exposure. Amerkan Journal of 

PublicHealth 78: 1191-1194, 1987. 

Robinson, J .C., Young, J .C., Rickert, W.S., Fey, G., 

Kozlowski, L.T. A comparative study of the amount 

of smoke absorbed from low yield (“less hazardous”) 

cigarettes. Part 2: Invasive measures. British Journal of 

Addiction 78: 79-87, 1983. 

Russell, M.A.H., Sutton, S.R., Iyer, R., Feyerabend, C., 

Vesey, C.J. Long-term switching to low-tar lownicotine cigarettes. British Journal of Addiction 77: 

145-158, 1982. 

Russell, M.A.H., Wilson, C., Patel, U.A., Feyerabend, C., 

Cole, P.V. Plasma nicotine levels after smoking 

cigarettes with high, medium, and low nicotine 

yields. British Medical Journal 2: 414-416, 1975. 

West, R.J., Russell, M.A.H., Jarvis, M.J., Feyerabend, C. 

Does switching to an ultra-low nicotine cigarette 

induce nicotine withdrawal effects? Psychopharmacology 84: 120-123, 1984. 

Wynder, E.L., Goodman, M.T., Hoffmann, D. 

Demographic aspects of the low-yield cigarette: 

Considerations in the evaluation of health risk. 

Journal of the National Cancer Institute 72: 81 7-822, 

1984. 

Zacny, J.P., Stitzer, M.L. Cigarette brand-switching: 

Effects on smoke exposure and smoking behavior. 

Journal of Pharmacology and Experimental Therapeutics 

246(2): 619-627, 1988. 

172 
Chapter 13 

Cigarette Design Technologies Reduce Smoke 

Yield and Expand Consumer Choices: The 

Role and Utility ofthe FTC Test Method 

David E. Townsend 

BACKGROUND The Federal Trade Commission (FTC) test method for measuring tar 

and nicotine yields of cigarettes provides accurate and reliable information. 

Comparison of yields of various brands is a key factor consumers use to make 

objective choices in the marketplace. Another key factor is the taste of the 

cigarette, which in most cases is related to the tar and nicotine yield. 

Calls for reduced tar yields from cigarettes came from the popular press, 

the scientific literature, and the public health community beginning in the 

late 1950’s. Many of these included statements that tar reduction would 

reduce the relative risks for certain diseases. 

The implementation of FTC testing for tar and nicotine in 1967 was an 

important step for cigarette manufacturers to communicate information on 

lower tar products to consumers for them to use to make informed decisions 

in the marketplace. 

Even at that time, FTC understood the limitations of standardized 

machine smoking and recognized that no standard method would be able 

to take into account the wide range in human smoking behavior: 

No two human smokers smoke in the same way. No individual 

smoker smokes in the same fashion. The speed at which one 

smokes varies both among smokers, and usually also varies with 

the same individual under different circumstances even within the 

same day. Some take long puffs (or draws); some take short puffs. 

That variation affects the “tar” and nicotine quantity in the smoke 

generated (Federal Trade Commission, 1967). 

The FTC also recognized that the FTC method could not predict the 

absolute smoke yield any individual smoker might receive from a particular 

cigarette: 

No test can precisely duplicate conditions of actual human 

smoking and, within fairly wide limits, no one method can be 

said to be either “right” or “wrong.” The Commission considers 

it most important that the test results be based on a reasonable 

standardized method and that they be capable of being presented 

to the public in a manner that is readily understandable (Federal 

Trade Commission, 1967). 

173 
Smoking and Tobacco Control Monograph No. 7 

Daniel Oliver, chairman of FTC, confirmed RC’S position on cigarette 

testing in a statement before a congressional committee: 

As a general matter, I believe that advertisements that accurately 

convey information on “tar” and nicotine content can be a 

valuable source of information to consumers. Advertising that 

provides comparative information on different “tar” and nicotine 

levels can be especially useful (Oliver, 1988). 

CIGARETTE The cigarette industry response to the public demand for 

DESIGN AND reduced tar and nicotine cigarettes is evident in the dramatic 

CHANGES IN THE decline in sales-weighted average tar yields over the past 40 years 

CIGARETTE (Figure 1). In the early 1950’s the average tar yield of cigarettes 

MARKET was around 38 mg per cigarette. Today that average is about 

12 mg per cigarette. Nicotine yields also have been reduced in a similar 

fashion, although to a slightly different degree because the available 

techniques reduce tar and nicotine yields with slightly different efficiencies. 

The techniques to reduce tar over the years include filtration, more 

efficient filtration (through different filter materials, fiber type and density, 

and filter length), filter ventilation, expanded tobacco, tobacco weight 

reduction, increased paper porosity or permeability, reconstituted tobacco, 

faster burning cigarette papers, and reduction of cigarette circumference. 

Figure 1 

Sales-weighted average tar and nicotine yields, 1954-1993 

174 
Chapter 13 

The physics and chemistry of a burning cigarette are exceedingly 

complex. For example, filter ventilation involves two mechanisms. In the 

first, fresh air from the outside is admitted to the filter and mixes with the 

smoke. As a result of this ventilation, a smaller effective puff is drawn on 

the burning end of the cigarette and less tobacco is then consumed during 

the puff. In addition, the smoke velocity in the cigarette is dramatically 

reduced, and the filter efficiency upstream of the ventilation holes increases. 

Similarly, in the second, a higher paper porosity also allows more outside air 

to enter the smokestream, also reducing the effective puff volume at the fire 

cone. The various cigarette design parameters result in many interactive 

effects on the performance of the cigarette. 

The changes in cigarette design to reduce tar and nicotine yields have 

not been limited to low-tar and ultralow-tar products. Even today’s 

nonfiltered cigarettes, the so-called high-tar brands, have about half the 

tar yield of their 1950’s counterparts. 

As a result, consumers today have a much wider range of choices in tar 

and nicotine than they did previously, and all cigarettes are substantially 

lower in tar yields than they were in past years (Figure 2). Cigarette design 

changes have resulted in an overall major reduction in smoke yields. 

Figure 2 

R.J. Reynolds Tobacco Company offers smokers a range of tar levels (1955-1993, 

in 5-year intervals) 

--- RJR high-yield 1-

---Industry sales-weighted average 

RJR low-yield 

1955 1960 1965 1970 1975 1980 1985 1990 1993 

Year 

175 
Smoking and Tobacco Control Monograph No. 7 

UTILITY OF Although it has been clear that humans do not smoke like machines, 

THE FK TEST it is also clear that changes in the FTC smoking conditions do not 

METHOD alter the relative ranking of cigarettes. The FTC conditions include 

a 35-cc puff of 2 seconds duration, taken once per minute. If the puffing 

conditions are changed, the relative ranking or yields of the cigarettes are 

preserved. 

For example, Figure 3 shows tar yield as a function of puff volume. 

In this chapter, puff volumes of 35 cc, 45 cc, and 55 cc were chosen for 

comparison of four cigarette products, one each from the lowest tar, 

ultralight, full-flavor light, full-flavor categories. The 35-cc puff is the 

ETC condition and is not intended to represent the lowest smoker puff 

volume; the other two conditions were arbitrarily chosen. As the puff 

volume increases, tar yield of the product in each category increases. 

However, the ranking of the categories is preserved. For example, the 

tar yield of an ultralow-tar product at a 55-cc puff volume is lower than 

the tar yield of a low-tar product at the same puff volume. 

Changing the puff frequency from one puff per minute to one puff every 

45 seconds or one puff every 30 seconds also increases the tar yield in each 

category, yet the ranking of the cigarettes is intact (Figure 4). Puff duration 

has little, if any, effect on the actual yields (Figure 5). 

Figure 3 

Effect of puff volume on observed tar yields 

25 I Puff volumes studied: 1 

20 

n 

2 15 0 

.-w

0 

\ 

YF 10 L 

s 

5 

Lowest Tar Ultralight Full Flavor Light Full Flavor 

Brand Style 

Note: The puff duration for this experiment was 2 seconds; the puff frequency was one every 60 seconds. 

176 
Chapter 13 

Figure 4 

Effect of puff frequency on observed tar yields 

35 

Puff frequencies studied 

(one puff taken every Y seconds): 

30 

25 

20 

15 

10 

5 

0 

Lowest Tar Ultralight Full Flavor Light Full Flavor 

Brand Style 

Note: The puff volume for this experiment was 45 cc; the puff duration was 1.7seconds. 

Figure 5 

Effect of puff duration on observed tar yields 

35 

30 

25 

20 

15 

10 

5 

0 

Lowest Tar Ultralight Full Flavor Light Full Flavor 

Brand Style 

Note: The puff volume for this experiment was 45 cc; the puff frequency was one every 30seconds. 

177 
Smoking and Tobacco Control Monograph No. 7 

Figures 6 through 8 show smoke nicotine yields for the same set of 

cigarettes; however, the smoking machine puffing conditions are different 

for each figure. Like tar yield, the nicotine yield goes up with increased puff 

volume and increased puff frequency, and the relative yields among the 

categories remain ordered. Puff duration also has little if any effect on 

nicotine yields. 

Standard methods are used to provide information to consumers for 

products other than cigarettes. A classic example is the estimated 

Environmental Protection Agency (EPA) gas mileage ratings for vehicles. 

Depending on driving habits, conditions, maintenance, and fuel type, a 

vehicle may get more or less mileage than indicated by the EPA estimate. 

Although few drivers will achieve the actual mileage listed for a vehicle, the 

mileage ratings do provide a means of relative comparison among vehicles. 

A potential buyer can use the information to determine if a particular vehicle 

would fit into his or her particular transportation and economic needs. 

Similarly, smokers have two primary considerations in making their 

choices in the cigarette marketplace. The FTC method provides comparative 

smoke yield information that is an essential part of that process. The second 

factor of taste is an individual preference that is made with the comparative 

information in mind. 

Figure 6 

Effect of puff volume on observed nicotine yields 

I .V 

1.4 

n 

Q)

f: 1.2 

2 

.-g 1.0 

e 

0.8 W 

0.6 .-

CI

0 

.o 0.4

z 

0.2 

0 

Lowest Tar Ultralight Full Flavor Light Full Flavor 

Brand Style 

Note: The puff duration for this experiment was 2 seconds; the puff frequency was one every 60 seconds. 

178 
Chapter 13 

Figure 7 

Effect of puff frequency on observed nicotine yields 

2.5 

Puff frequencies studied 

(one puff taken every ‘k”seconds): 

s 2.0 

t:

f

-= 1.5 2 

YE 

Q) 1.0

.-E

4-

8

2 0.5 

0 

Lowest Tar Ultralight Full Flavor Light Full Flavor 

Brand Style 

Note: The puff volume for this experiment was 45 cc; the puff duration was 1.7seconds. 

Figure 8 

Effect of puff duration on observed nicotine yields 

2.5 

Puff durations studied: 

E 

2.0 

f 

.-tn 1.5 

2 

-

F 

1.0 

Q)

.-c

4-

0 

0

2 0.5 

0 

Lowest Tar Ultralight Full Flavor Light Full Flavor 

Brand Style 

Note: The puff volume for this experiment was 45 cc; the puff frequency was one every 30 seconds. 

179 
Smoking and Tobacco Control Monograph No. 7 

QUESTION-AND-ANSWER SESSION 

DR. BENOWITZ: How do you reconcile the differences between your data 

and other data that show when you get down to very low yields of nicotine, 

you are getting to a cotinine level of 225 vs. maybe 325 or so at the higher 

levels, in over 2,000 people. Do you think that is less accurate than your 

data in 33 subjects? 

DR. DEBETHIZY: I think that the method of measuring plasma cotinine is 

a less accurate measure of nicotine uptake. 

DR. BENOWITZ: What bias do you think there is in cotinine that could 

explain the tremendous difference in findings? 

DR. DEBETHIZY: I do believe the data that we have. And I am surprised at 

them, based on what I know about the cotinine data in the field studies. 

Now, that does not mean that the data we have are wrong; it may be that 

at lower yielding products, that what people do over the course of an entire 

24-hour period is different from what would be measured, say, at either 

9:OO o’clock in the morning or 3:OO o’clock in the afternoon, depending 

on where people are measuring those plasma samples. So, I would say that, 

yes, the number is much larger for those plasma cotinine studies. But the 

point is that, even with those studies, compensation is incomplete. People 

smoking lower yielding cigarettes absorb less nicotine. Now, I would 

conclude the same thing from both data sets. 

DR. BENOWITZ: I want to go back to your statement when you said the 

FTC method is accurately reflecting intake, because I think that is patently 

wrong. It is not whether there is some reduction; it is whether you can look 

at those cotinine levels, which would indicate that, when you get below 1 mg 

nicotine, that the FTC method is underestimating consistently based on 

cotinine levels in a couple of thousand people. 

What I am arguing about is, is it reasonable to generalize from your 

33 subjects and say that is more valid than the 2,000? 

Cotinine levels, as you know, vary throughout the day, but not more 

than 10 or 15 percent if you are smoking regularly. So, there is no way that 

10 or 15 percent can explain the difference, even if there were the worst bias 

that you can imagine. 

DR. DEBETHIZY: I think that we can generalize from the data. I do not 

think we can give those data the weight that 10years of analysis has 

provided us with. But I think that if we look at the plasma cotinine data, 

people smoking lower yielding cigarettes absorb less nicotine. Those data 

clearly show that. 

They do not show that people get the same amount of material from all 

the wide range of nicotine-yielding cigarettes; would you agree with that? 

180 
Chapter 13 

DR. BENOWITZ: There is a slope such that there is not 100 percent 

compensation, although it may be close in some studies. But I would agree 

that there is a slope. 

DR. DEBETHIZY: And I think that what we have done is taken things to the 

next step, what Dr. Henningfield called for earlier in his talk, which is to 

apply a technique that is used for other materials. 

If you were asking what the amount absorbed of a pharmaceutical 

product in a 24-hour period would be, you would measure the total amount 

excreted and sum it up. That is all we have done, and I think that the data 

deserve consideration. I think that additional work will determine whether 

that slope will stay as steep as it is now. 

I think you will notice that there were people above and below that, so 

there is wide variation. But the point is that people smoking lower yielding 

products are absorbing less. How much less, I do not know, and I suspect, 

even with our own data, we see some evidence that at the lowest yields, they 

are absorbing more than FTC would predict. 

DR. RICKERT: First of all, in looking at your data on the FTC yield and the 

nicotine, one is impressed by the fact that it looks like there are basically two 

points on that regression. One is at the very low .1 mg and the other one is 

up at 1.4. 

It seems to me that, for the bulk of the data, there is no relationship, that 

it is really a two-pronged display, with one at the bottom and one at the top 

and in the middle. 

DR. DEBETHIZY: And I think that what you are looking at is the fact that the 

two center groupings are very close in nicotine and tar yield, but of course 

there is a full range of products out there on the market, and that is what we 

wanted to address with that. 

DR. RICKERT: In reading the industry documents, it has been stated time 

and time again that consumers understand the FTC tar numbers. And my 

reading of the literature and what I have heard today suggest that is not so. 

And I was wondering whether there is industry information that supports the 

hypothesis that consumers, indeed, understand FTC numbers of tar and 

nicotine? 

DR. TOWNSEND: How could the industry have changed so dramatically 

over the years and people traded taste, if tar levels were not a consideration 

in their choice? 

People tell us, in focus groups and in other ways, “Yes, I am concerned 

about what I believe are health risks in smoking.” They have been told that 

for 40 years, and they respond by looking at the tar levels of the products 

that they choose in the marketplace. 

181 
Smoking and Tobacco Control Monograph No. 7 

DR. RICKERT I guess the question I am asking is, How do you reconcile 

that point of view with the information that has been provided here today, 

which suggests that the majority of smokers do not understand FTC 

numbers? 

DR. TOWNSEND: I am convinced that they understand tar ratings as a 

relative comparison, the same as I think we understand EPA gas mileage. 

When you go buy a new car, EPA gas mileage estimates are determined 

by a number of factors, including the type of engine, how you drive, how 

properly you inflate the tires, how well you maintain it, how good your 

mechanic is, and even maybe the region of the country in which you live, 

because gasoline engines are more efficient in certain climates than others. 

I do not take EPA gas mileage ratings to mean that is what I am going 

to get. The same as I was referring to earlier, I do not think I am necessarily 

getting the same efficiency on my hot water heater as it is rated. 

I think these ratings are for comparison purposes. And I think that is 

what most consumers look for in the marketplace, and I think that is the 

way they interpret the FTC numbers. 

DR. RICKERT: Let’s assume for a moment that the FTC numbers are a perfect 

predictor of the amount of nicotine that is obtained from a cigarette. How 

do you think that relates to the other components that may be of concern? 

There are a whole host of chemicals that are related to various disease 

phenomena. How do you think the blood nicotine levels will act as a 

predictor of the absorption of these other constituents? 

DR. DEBETHIZY: I think that one of the things about nicotine as a marker 

is that nicotine represents probably the upper limit for a particular phase 

for constituents. But one thing that I want to remind everybody is that the 

FI’C method was never intended to measure or assist people with the actual 

uptake. It is to provide a relative ranking of cigarettes. And I think it has 

reliably done that for a long time. 

It also gives us a way that we can standardize the analysis of cigarette 

smoking, so that we can compare work done in our laboratory with work 

done in your laboratory. And it has done that very well for a long time. 

DR. HARRIS: I wondered if you could show, once again, one of your slides 

showing the trends in the sales-weighted tar and nicotine averages over time. 

And also, you might put up the one of unfiltered Camels also, if you have it. 

It is not essential which one, and I think Dr. Hoffmann even had one. 

Dr. Hoffmann showed a similar slide, although the axes were labeled 

somewhat differently. And I have also looked at data on sales-weighted 

average nicotine, using the FTC numbers, at least those that were provided 

at various times to the Federal Trade Commission. 

And I have been led to the general conclusion that, while the FTC-based 

numbers declined substantially during the 1950’s and continued to decline, 

182 
Chapter 13 

to some degree, during the 1960’s, in the last 10 years, there has been 

basically no change in the sales-weighted average, whether you measure it 

by the distribution of tars with a percentage of brands under 15 mg or by 

the sales-weighted average nicotine. 

And in fact, data for 1992, and what I can estimate myself from 1993 

and 1994, are a slight upturn in the sales-weighted average nicotine, 

If you show your slide on Camel nonfilters, the graph ends in 1982 at a 

tar level of 20.6. It would be interesting to have the data for after 1982. 

DR. TOWNSEND: The tar delivery for Camel nonfilter is virtually flat from 

1982 to the present. This is a chart that I prepared for something else, not 

this. 

DR. HARRIS: And my question is really, What, if any, observations you 

might want to make about what appears to be progress in the decline in 

FTC yields during the last 30 years, a progress of which is really confined 

to the preceding two decades, with no change in the last decade? 

If this had been a meeting on mileage in the car industry, somebody 

would be waving a finger and saying, “What have you guys done in the 

last 10 years with your car model?” 

DR. TOWNSEND: My response to your question, first, is that I believe this 

clearly points out to me the need for the industry to respond with low-tar 

products that have improved taste characteristics. Clearly that is what 

consumers have told me: “I trade in tar for what I perceive as a possible 

benefit, and what I get is less taste.” The concept of low tar, great taste, 

does not wash with consumers. 

There are taste deficiencies in the lowest end. Some people choose to 

make that trade because, again, they weigh both factors in the marketplace: 

taste and tar levels. 

But I think both factors are important in their choice, because there are 

many, many smokers who do buy products in the lowest category; again, 

back to the need for some useful and valid comparative information on tar 

levels, and that is already in the market. The FTC test method provides 

valid and reliable information. 

First, beginning in 1981 or 1982, the price of cigarettes in the United 

States began to rise much faster than the rate of inflation. And at the same 

time, we saw a dramatic increase in generic and branded discount cigarettes. 

To some degree, the apparent stagnation in tar and nicotine levels 

may reflect smokers choosing to go from branded to discount and generic 

cigarettes. In fact, from what data I have seen, the major source of brand 

switching in the last 10 years has been to the discount and generic segment 

of the market, which, as you know, is about 35 percent of the market in 

1993. 
Smoking and Tobacco Control Monograph No. 7 

Another possibility that has been raised by some is whether some brands 

have had their nicotine levels and tar levels actually reconstituted upward 

slightly. 

A third is the changing demographics of the market. As some people 

quit and other people start, the average smoker is a different person who 

would intend, on average, to smoke a higher tar or higher nicotine cigarette. 

Finally, there is the question of whether or not, in fact, there is a limit 

that smokers are willing to tolerate, given the current cigarette array of 

choices. 

How does your hypothesis relate to the question at hand: What is the 

meaningfulness of the FTC test, and is it useful in the market? 

DR. HARRIS: There are several points you make. One is whether the test is 

useful, but also whether the industry has accomplished anything in reducing 

tar and nicotine levels. And I think that, since that was a preamble of both 

talks and it is certainly an issue that I have been puzzling over, I thought it 

was important to wrestle with the question of why have tar and nicotine 

levels not fallen in the last 10 years, and is there anything that can be done 

about it. 

DR. SHIFFMAN: You have very much emphasized the issue of consumer 

choice and consumers making a choice based on accurate information. 

I take it, then, that if consumers could be provided with better, more accurate 

information about yields, that is something that you would favor. 

DR. TOWNSEND: I believe that what the consumer needs is there. The FTC 

method provides reliable comparative information. 

DR. SHIFFMAN: You do not want them to have better information? 

DR. TOWNSEND: Convince me that there is better information. I am not 

convinced that there is. 

DR. SHIFFMAN: I am asking it as a hypothetical question. 

DR. TOWNSEND: If there is important information that the consumer needs 

to make choices in the marketplace, then I want to know it. 

DR. SHIFFMAN: We have seen individual variability around the trend line, 

and if we were able to provide individuals with information about where 

they stood on that, then would that be an improvement that you might be 

able to support? 

DR. DEBETHIZY: That is a tall order for any sort of standardized method. 

DR. PETITTI: Your talk, Dr. deBethizy, referenced the historical context of 

the development of the FTC measures. And the historical context was the 

claim that these measures would significantly reduce the risk of disease. 

Do you think that the data so far support a claim that these FTC measures 

predict or are meaningfully related to disease risk? 

184 
Chapter 13 

DR. DEBETHIZY: Personally, I do not know. But what I would say is that 

the data that I saw Dr. Samet present today, which were largely taken from 

the 1981 Surgeon General’s report, their conclusion was that people smoking 

lower yielding products have reduced relative risk for lung cancer. 

DR. PETIITI: I think that you saw the quotes from Dr. Wynder and some 

of the earlier commentators. They mentioned 40-percent reductions in tar 

might lead to large reductions in lung cancer. I just want to get a sense of 

the magnitude in the reduction of disease risk with differences in tar levels 

over the range we are talking about. 

I just want to make the point that adjustment is the problem; when you 

adjust, you assume people smoke the same number of cigarettes, whether 

they smoke high yield or low yield. And it is very difficult to handle 

statistically and is, I think, one of the problems in the original data that 

were published in the 1981 report. 

DR. DEBETHIZY: But you know, on average, that people smoking lower 

yielding products do not smoke more cigarettes. 

DR. BOCK: I am having a little bit of a problem. You had mentioned some 

observations with staining of saliva regarding ventilation and hole blockage. 

It seems to be the opposite from what was reported. Can you give me some 

details of how you know you got saliva on the area covered by the lips in 

every case, or most cases? 

DR. TOWNSEND: What I can do is give you detailed information on the 

whole experiment. And I will have to do that privately, because I don’t have 

the information with me today. 

What I said earlier is the case. We saw infrequent hole blockage, but 

there was hole blockage in some cases, and we determined that by an 

inhydrin staining process. And I cannot recall the details and the numbers, 

because I really was not responsible for that experiment. I would be happy 

to follow up with you on that, if you are interested. 

DR. COHEN: Let me quickly state what I think the premises are of your 

presentation, Dr. Townsend, and see if you disagree with where I disagree. 

Suppose we accept the premise that the FTC system provides useful 

ranking information, everyone understanding the difference between 

ranking and other kinds of information. Let’s say the system does that. 

Suppose we also accept the premise that truly individual smoking 

characteristics are beyond the scope of such a rating system. 

Now, you have established that there are product design features-type 

of paper, type of tobacco, etc., that lead to different yields because of 

smoking parameters that vary with such product design elements, such as 

puff rate, puff volume, etc. 

185 
Smoking and Tobacco Control Monograph No. 7 

Doesn’t this mean that a numerical scale-say, from 1to 27-is 

necessarily misleading and that a categorical rating system would be a more 

valid way to report such information? You had four categories, I believe, and 

you showed variance. What I am saying is, I was following that, and it 

looked to me like you were about to recommend a four-category system. 

DR. TOWNSEND: The whole idea of a categorical system, or so-called banded 

system, has been put on the table by a number of people in the past. 

Conceivably, that accomplishes the same endpoint with one exception, 

I believe. The same endpoint, of course, is that it provides a comparative 

ranking for consumers. The flaw in that approach, if that is the only 

ranking, and discrete numbers are not also included, is that, of course, 

you would expect products to come up against the ceiling of each band. 

DR. COHEN: I thought you established, with your own analysis, that 

individual numbers were inherently misleading? 

DR. TOWNSEND: I did not say that individual numbers were misleading. 

In fact, I believe individual numbers-a numerical rating system-is, in fact, 

the best and that is what the FTC test method is. 

With those data, then, manufacturers have advertised their products as 

light or ultralight, to fit some range of tar numbers. 

DR. COHEN: I think you missed my point. 

DR. TOWNSEND: The FTC method is the method that provides the useful 

comparative information for the smoker. 

DR. COHEN: I thought you established with your charts that there was 

variance due to what is technically an interaction between product design 

characteristics and smokers’ adaptations to them. Is that correct? 

DR. TOWNSEND: Okay, you are confusing me. Let me put the chart back 

up. Standard deviation for replicate measures of that particular product. 

Different particular puff frequencies. Puff frequency of 60 seconds happens 

to be blue bars, 45 seconds is the red bars, 30 seconds is the yellow bars. 

So, the ultralight product that was smoked at 30-second frequency-in fact, 

this is the variability we saw in 10 replicate measures of that one cigarette. 

DR. COHEN: Okay, then I did misunderstand that, but a lot of the 

presentations today have essentially suggested that smokers respond to 

product design characteristics by modifying behavior. And I am not talking 

about idiosyncratic behavior, but standard ways that you put up-puff 

frequencies, puff duration, number of puffs. 

That creates variance around a point estimate. And would it not be 

more valid to acknowledge that those variances exist when you provide this 

information to consumers? Ranking is the least informative scale. 

DR. TOWNSEND: You are talking about something like the EPA gas mileage 

ranking, where you have highway and city. 

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Chapter 13 

DR. COHEN: Ranking information has only an ordinal property. The 

absolute numbers have no significance, nor do the units of measurements 

between-like 16, 17, 18, 19. In a ranking system, you never assume those 

units are equal. 

In this system, presented to consumers, consumers have a right to 

assume equal appearing units-16, 17, 18, 19. It goes beyond a ranking 

system. If you just want a ranking system, then there are ways to do that, 

to build on this kind of variance. 

So, if all you want is a ranking system, the one that is in place now 

attempts to do more than that, and I thought your evidence indicated that 

it did not do it with great validity. 

DR. TOWNSEND: What variance are you speaking of? 

DR. COHEN: The interaction of human smoking topography and cigarettes 

having different design features. 

DR. TOWNSEND: Have you quantified that? 

DR. COHEN: I have not done it. I think we have discussed it today. I am 

not a technical expert on it. I am asking from the standpoint of consumer 

usefulness. 

If a ranking system could be preserved to meet your objectives that 

you set out and, at the same time, it would have more validity because it 

wouldn’t represent units that do not exist because there is too much variance 

around them; it is only a ranking system. 

DR. DEBETHIZY: It sounds like you have put a proposal on the table, and 

my impression is that is what we will do tomorrow. 

DR. COHEN: It sounded like you were saying, “Well, if it achieves its 

purpose as a ranking system and leaves consumers to know which brands 

are lower and which are higher, and that is fine.” 

DR. DEBETHIZY: And we think that the current method does that. So, I will 

be looking forward to the discussion tomorrow about alternative methods. 

DR. HENNINGFIELD: This is actually a nice introduction to my point. 

Compensation is one of the reasons that you get a good correlation with 

machines and a lousy correlation with humans. It is not validated that the 

FTC method predicts what humans get. 

But you have seemed concerned that compensation was not perfect, 

as though the fact that it was not imperfect rejected the notion of 

compensation. 

DR. DEBETHIZY: I think what I was doing was challenging the notion that 

people get the same amount from every cigarette on the market. 

DR. HENNINGFIELD: Do you know of any drug study with humans with 

addictive drugs where you do get perfect compensation? 

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Smoking and Tobacco Control Monograph No. 7 

DR. DEBETHIZY: I just do not even see a reason to address that question 

because smoking is a habit that people engage in, and people enjoy smoking. 

I think we have a situation where people enjoy smoking; they have a wide 

range of products to choose from; they can choose lower yielding products. 

The data-whether it is plasma cotinine or total urinary uptake-show 

that they get, when they smoke lower yielding cigarettes, less material, 

on average. 

Now, the FTC method was never intended to address that question. 

It was intended to address the relative ranking of cigarettes. 

DR. SHIFFMAN: Actually, what your data show is that within the broad 

range in which sales are actually concentrated-let’s say from .4 to about 1.0, 

1.2,FTC nicotine-people are getting, on average, the same, regardless of the 

nominal yield. So, in fact, your own data, as Dr. Rickert pointed out earlier, 

suggest that, in fact, the numbers do not track. 

DR. SHIFFMAN: What your data show is that people who smoke cigarettes 

of .1 are very much lower than people smoking 1.4. But if you look at the 

middle range, we could probably compute the correlation by tomorrow, but 

I would warrant that it is close to zero. 

DR. DEBETHIZY: And the middle range is a very narrow range of tar and 

nicotine yield. 

DR. HENNINGFIELD: Let me just bring closure to my point, because what 

I see-and I think Dr. Shiffman is pointing out, too-is that what you see 

with humans with other addictive drugs, and what you see in animals, is 

compensation that is partial. And that seems to be what we are seeing here: 

another case of an addictive drug that controls behavior, and you do get 

compensation, although it is not perfect. That seems to be the biological 

process going on. 

DR. TOWNSEND: And I think you and I fundamentally disagree about 

that, because it is like coffee drinking. I do not see myself as being, if I drink 

1 cup of coffee 1 day and 10 cups of coffee the next day, I do not see that 

as compensation. I just see that as responding to different situations and 

choosing to drink coffee under those different environmental conditions. 

And I see smoking as a very similar activity that people engage in. 

DR. KOZLOWSKI: This is a supplement to Fred Bock’s question and point. 

Years ago, in Toronto, we tried to do a saliva test, I think similar to the one 

you did. We collaborated with the forensic laboratory for the Province of 

Ontario, and a Ph.D. student in pharmacology worked on it. 

And we never published it because we did not find it useful, in part 

because the lips, in general, were too dry and were not depositing that 

much saliva and were doing it in a very soggy manner. 

We found that a much more straightforward technique would be to take 

chapstick or lip gloss, and that would stain the filter overwrap. You could 

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Chapter 13 

then dissect the cigarette and count the holes that have been blocked by 

that. We tried that technique and abandoned it as unsuccessful. 

Just months ago, we published in Pharmacology, Biochemistry and 

Behavior a validation of the stain pattern technique using Marlboro Lights, 

Winston Lights, Marlboro Ultralights-I am not sure about the four or five 

other brands. They worked just fine. 

Even with ventilated filter cigarettes, which may be ventilated in the 

20-to 30-percent range rather than 80 or 90, you can get a team of raters 

to do reliable judgment. 

DR. DEBETHIZY: I think what is important is that some individuals may 

block holes when they smoke cigarettes. What is important is what happens 

over the course of their entire smoking day and what happens, on average, 

with people. And I think there has been an incredible emphasis placed on 

blocking holes here today, and I think that Dr. Townsend’s talk clearly 

showed that there are many, many other techniques used to lower tar and 

nicotine, techniques that could not be overcome by the smoking behavior 

of the individual. 

DR. FREEMAN: What I am going to do is say to cut this at this point and 

maybe we can continue it tomorrow. We were due to be finished about 

20 minutes ago. It may be a little hard on these two gentleman, who have 

been very gracious in answering these questions. We do not want to put 

them under too much, but we would like to bring you back tomorrow, if 

you do not mind, for further discussion. But let’s have these two questions. 

DR. BENOWITZ: There has been some suggestion about providing the 

consumer with more information, such as making ventilation holes visible 

so that people can see them and not block them, and give them information 

about what intense smoking would do, which you could simulate by 

machines. Are there any negative aspects about doing those things, from 

your perspective, and why not provide more information like that? 

DR. DEBETHIZY: I think Dr. Townsend addressed it earlier when he 

responded that we would consider any reasonable proposal as long as there 

were some data to support that proposal. 

And I am assuming that is what you all will do, and at least start the 

process. And you all may conclude that the FTC method is fine as it is, but 

I certainly do not have any problem with looking at reasonable proposals. 

We have a motto at our company that we work for smokers. And if we 

can be convinced that it is meaningful for the consumer, that might warrant 

consideration. 

DR. TOWNSEND: But you understand that we believe, today, that the FTC 

test method is useful for the consumer; that its presence has been beneficial 

for consumers making choices and also for driving the industry to reduce tar 

and nicotine levels to this great extent that we have. 

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Smoking and Tobacco Control Monograph No. 7 

Then the other point, too, ISO-the International Standards 

Organization-of course, adopted a standard test method that is used 

throughout the world, that is essentially the same. And they, in the 

investigations, particularly in Germany and the UK, had many of the 

same questions here. 

DR. BENOWITZ: But there is no drawback for providing more information. 

DR. TOWNSEND: Oh, absolutely. I think we always have to look at new 

information that is available, and look at it in depth, critique it, and see if 

anything is there. 

DR. HOFFMANN: I am somewhat puzzled. I have seen the tobacco field for 

decades, and I always found the tobacco industry to be flexible. The pressure 

from the consumer and from the scientific community led to the industry 

changing the cigarette. And you have in Science the outstanding study by 

Dr. Benowitz. 

We all agree that there is some compensation, and I find that you are 

inflexible. We have to work on it; there is a way. I am surprised. I have, 

in all the X years I have been working in this field, I have never seen such 

an inflexible thing as this, where you stick to the FTC method. 

I think we can always improve, and U.S. scientists know this just as 

well as I. 

DR. DEBETHIZY: Let me ask this question. Have you seen a proposal put 

on the table that seriously would improve on the current method? 

DR. HOFFMANN: The advances in the research have been done by both 

sides-by industry as well as the scientific community. Suddenly, I find that 

you say, “No, the FTC method is the final word.” 

DR. DEBETHIZY: I think that clearly what we have said is that, with 30 years 

in a standardized method that has been incredibly valuable to consumers, 

the industry, and the scientists that we have not seen any reason to walk 

away from that. I would just give it back to the group and say, let’s see a 

serious proposal. 

DR. TOWNSEND: I am sorry that you are misreading this as being inflexible. 

I think the fact is that the FTC method has worked for a long time, and it 

continues to work. 

But demonstrate what the proposal is, and how it adds to what we have 

now, to make things better, or to provide some more information. For 

example, one of the proposals that was floated this morning included a 

min and max level. Okay, let’s smoke a cigarette at FTC conditions, and 

then let’s go to a more intensive smoking condition, to report min and max. 

What is going to happen from that is that you get exactly the same 

ranking; it is just more numbers, but it is the same ranking. And consumers 

are making their choices based on ranking. 

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Chapter 13 

DR. HOFFMANN: But you have shown here, in your paper, it is very detailed. 

It is for the low-yielding figure and compensation. 

DR. DEBETHIZY: Yes, and you are right about that. 

DR. HOFFMANN: So, this is not a reason that we should work together? 

DR. DEBETHIZY: And we are quite willing to work with anybody, and that is 

why we are here today. 

DR. FREEMAN: Dr. Townsend, I just want to ask one question, and it may be 

a little naive. Several times you have mentioned the value of tar in cigarettes 

because you say it is associated with taste. Even conceding that although it 

seems to be a thing that is killing people. 

But what about nicotine? What it is the value of nicotine and cigarettes, 

and why could it not be dramatically reduced? 

DR. TOWNSEND: Nicotine, of course, is part of the smoking sensation. It 

does provide a sensation to the smoker. I think one of our competitors found 

that tobacco that had been treated to remove all the nicotine was not 

successful in the marketplace. 

More than that, just as I cannot look into the components of tar and say, 

this is a very important, tasteful, and flavorful compound. You know, I am 

not equipped as a chemist to say nicotine is an important compound for this 

aspect of taste characteristics. 

DR. FREEMAN: We will stop at this point. 

REFERENCES 

Federal Trade Commission. “FK To Begin Cigarette Oliver, D. Prepared statement by the Federal Trade 

Testing.” News release. August 1, 1967, p. 2. Commission chairman before the U.S. House 

Subcommittee on Transportation, Tourism, and 

Hazardous Materials, Committee on Energy and 

Commerce. May 4, 1988, p. 11. 

191 
BLANK PAGE 
Section 11 ~~ ~~~~ 

Transcript ofSecond-DayDiscussion 

DR. FREEMAN: Good morning, everyone. I would like to welcome all of the 

speakers and panel members and the audience back to these deliberations. 

We will continue to deliberate concerning the FTC test method, and we will 

begin this morning with continuation of the dialog that we were having 

with Dr. Townsend and Dr. deBethizy, who represent the tobacco industry. 

DR. BENOWITZ: I would like to follow up with two questions on why the 

results from the study of 33 subjects relating the total nicotine recovery vs. 

the FTC yield from cotinine studies are so different. The first question is, 

since these results were so different, it would be very interesting to have 

measured cotinine levels in these smokers, as well as looking at urinary 

metabolites, and I would like to know if that was done and if we could 

see those data. The second thing I was wondering was, since this question 

of yield versus intake has been so important for so many years and since 

R.J. Reynolds has the capability of doing it, I wonder if they have ever done 

a study like the ones that I showed where they looked at cotinine levels 

vs. yields in a large population just to see if their own work would replicate 

the work of other people, and it seems like a very straightforward study 

that would be something they might have done. 

DR. DEBETHIZY: The answer to your first question is no, we did not measure 

plasma cotinine in those studies. We were studying nicotine metabolism 

interindividual variation. That was how we got into that work, and we 

extended it then to ask the question across the tar categories. In the study 

that we are currently doing, we are actually measuring salivary cotinine. 

We made a conscious decision not to measure plasma cotinine because we 

did not want to interfere by taking a blood sample. So, we are doing salivary 

cotinine in that study to answer the exact question that you have raised. 

I think that is a good question to ask. In subjects where we see lower total 

nicotine output, are the plasma concentrations higher? That is a good 

question. And your second question was? 

DR. BENOWITZ: There were data from Dr. Gori’s work that I presented that 

were supported by Brown and Williamson, I believe. We basically looked at 

cotinine levels vs. yields for a large population, and I think those data were 

very important. I was wondering if R.J. Reynolds has ever done such 

a study, and if any data are available addressing that question? 

DR. DEBETHIZY: We have not done a field study. There were so many field 

studies in the literature already, we just have never done a study like that. 

DR. SHIFFMAN: Just to follow up on that study, a couple of us were pointing 

out that the relationship seemed to be very much driven by the extremes, 

and I took the liberty of computing what the correlation would be in those 

same data if one excluded the very extremes. I had to impute the data from 

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Smoking and Tobacco Control Monograph No. 7 

the graph, but if you look at the data above .13 and at or below 1.02 FTC 

yield, the correlation is .16. In other words, except for the extremes in your 

own data, there is no relationship. 

DR. DEBETHIZY: Yes, it is interesting to me. I think what we have done 

is taken the best available technology, done what Jack Henningfield asked 

people to do, which is to take a look at things using modern techniques, and 

we have done a study that I think causes us to stop and think about what 

the previous data have shown. We can manipulate those data to get them 

to look like what the other data look like, or we can take them on their own 

merits, and I think that what we need to do is follow this study up with 

further work, and that is why we are doing that, and I have encouraged 

Dr. Benowitz to do the same thing. I have encouraged the Swedish Tobacco 

Company, which has the capability to do the same thing. 

I think rather than doing some data selection on this particular study 

we should take it on its own merit. It is a 33-person study. It suggests that 

when smokers can freely do their activities, people consuming lower yielding 

cigarettes absorb less nicotine. Now, it also suggests that there is large 

interindividual variation, and I think lots of people have pointed that out. 

When you do a study like this, you are going to get extremes because 

people smoke cigarettes across a wide range, and I think you have to include 

those people, and I think as we and others fill the data in over time we will 

find out whether this correlation or the slope of this line is as steep as it is 

now or whether it is shallower, and I just think we need to continue to do 

that work. We have worked hard to develop a state-of-the-art technique, 

and I think it has merit. 

DR. SHIFFMAN: I think it has merit, too, and I applaud you for doing it. 

At the same time we ought to be clear on what the data show, and the data 

show that people smoking brands above 1.03 are getting more than people 

smoking brands at about .13 and that in the middle range there is no 

relationship to the FTC yield. 

DR. FREEMAN: Dr. Benowitz, does that answer both of your questions? 

DR. BENOWITZ: Yes. 

DR. FREEMAN: Dr. Rickert? 

DR. RICKERT: In the media recently, the cigarette Eclipse was described, and 

it is obvious from the media description that the cigarette is going to pose 

some challenges for the FTC methodology, in particular because it does not 

burn down to a fixed butt length. There are some other challenges that may 

be posed by that cigarette to the FTC methodology, and in particular I am 

wondering about the distribution of nicotine between the gas phase and the 

particulate phase. That is, in the current FTC methodology when testing the 

Eclipse cigarette, will the amount of nicotine that is being delivered by that 

cigarette be trapped using the traditional Cambridge Filter method? 

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Section I1 

’ 

DR. TOWNSEND: I do not think we really know the answer right now to 

the question of nicotine distribution between the gas and particulate phase. 

I do think we have confidence that the FTC method can provide useful data 

for Eclipse. Certainly the FTC method will have to be accommodated for 

that product in much the same way that the FTC considered accommodating 

the method for Barclay and the use of different holders. That proposal 

was certainly up for discussion. The FTC method as it stands with some 

modification, particularly for the fact that Eclipse does not burn down, 

can provide useful data for that. 

DR. FREEMAN: Dr. Henningfield? 

DR. HENNINGFIELD: In dealing with the smokeless tobacco issue, which 

has no labeling, and I think that is a problem, it struck me yesterday that I 

am not sure what is worse, having no labeling or having labeling that might 

be misleading to consumers about relative risks. In trying to deal with the 

relative risk issue yesterday, you spent a lot of time talking about your 

technologies that address health concerns and implying that there was some 

health benefit, and I would like to know what your estimate is as to the 

number of cancer deaths, for example, caused by standard cigarettes and 

how many lives, if any, would be saved if people were using cigarettes with 

these advanced technologies of filtration and so forth that you were talking 

about yesterday? In other words, how many people die of cancer in your 

estimation from the higher yield cigarettes, and how many fewer, if any, 

would die from the lower yield cigarettes? 

DR. TOWNSEND: I think what you did was completely mischaracterize what 

I said yesterday. What I said was that the Surgeon General and the public 

health community called for the reduction in tar and nicotine yields from 

cigarettes, and I said that the industry and R.J. Reynolds responded to that 

consumer demand through major design changes to the product, and we 

successfully reduced the tar and nicotine yields from the very high ~O’S, 

as a sales-weighted average, down to currently about 12 mg. 

DR. FREEMAN: To follow up on the question, do you think that fewer 

people die based on the changes that you have made? 

DR. TOWNSEND: I am not an epidemiologist. The Surgeon General in 1981, 

in his report, did say that reduced-tar products pose a reduced health risk. 

DR. HENNINGFIELD: I would like to follow this though because the words 

“light” and things like that are only used with foods when there is a health 

benefit. Your industry is using those terms relating them to FTC yields, and 

I would like to know what your estimate of the health benefit is. To know 

that, we have to know what your estimate of the death rates are with the 

different products. 

DR. TOWNSEND: I just said that I was not an epidemiologist. I happen to 

be a chemist. I do know what the Surgeon General and epidemiologists have 

said. Many smokers have heard the same thing. 

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Smoking and Tobacco Control Monograph No. 7 

DR. FREEMAN: Dr. Hughes? 

DR. HUGHES: I would like to ask your opinion about ordinal vs. cardinal 

scales because I think that was not made clear yesterday. You compared 

the ETC method to the EPA gas mileage. If I buy a car that has 38 miles per 

gallon and my sister buys a car with 19, I get twice what she gets. Now, 

even your own data show that is not true with tar and nicotine yields. 

When you have a tar yield that is twice another cigarette, you do not get 

twice the tar. So, I find those numbers misleading. I think the normal 

consumer when they see a cigarette that says, “1 milligram tar,” and they 

see another cigarette that says, “8,”they think they are getting one-eighth 

the tar, and that is not true. It seems to me if that is the case, and all you 

want is rankings, that we should do away with the numbers because they 

are misleading, and I would like to hear your thoughts about that. 

DR. TOWNSEND: A relative ranking of cigarette yields is what is essential 

in the marketplace. To date we believe that the FTC method provides useful 

information for the consumer. Do you really believe that your car gets 

19 miles per gallon when you drive it? 

DR. HUGHES: I believe that my car that gets 19 gets half the mileage of 

somebody else’s car that gets 38, and I think most consumers would believe 

that if they saw the numbers 19 and 38. 

DR. DEBETHIZY: But what else is on that label? The other part that is on 

there is, “Your actual mileage may vary,” and that is important because again 

this particular method was not set up to predict what an individual will get. 

It was set up for relative ranking, and I think it is really important to stick 

with that. 

DR. HUGHES: I agree, and with relative ranking, when you have rankings 

and ordinal categories, you do not have numerals attached. 

DR. DEBETHIZY: You just gave a good example of that when you gave EPA 

gas mileage. 

DR. HUGHES: EPA gas mileage is a cardinal system. It is not a relative 

ranking. The EPA gas mileage, 38, cars that have 38 miles per gallon do, 

in fact, get twice the mileage as cars of 19. 

DR. DEBETHIZY: Only if driven under standard conditions. 

DR. HUGHES: No. You are confusing variability around the mean with 

ordinal vs. ranking. 

DR. DEBETHIZY: I think I understand the difference, and I think that we 

could argue about this all day, but I think that the FTC method was intended 

as a machine-based standardized method to provide relative ranking, no 

more than that. 

DR. FREEMAN: Dr. Henningfield? 

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Section II 

DR. HENNINGFIELD: Then if we play by your rules, what is wrong with 

putting on the cigarettes, “Your intake may vary on a cigarette that is socalled an ‘ultralow”’ and put right on the cigarette, “You may get up to 

3 mg of nicotine and 80 mg of tar from this, depending on how you smoke 

it”? What would be wrong with that? Wouldn’t that just provide honest 

information to consumers so that they would know? Maybe even giving 

them a little bit of information that you folks know and we know about 

what pushes it up there, such as smoking harder and things like that; what 

is wrong with that? 

DR. DEBETHIZY: As I said yesterday, we are quite willing to consider any 

reasonable proposal, and I suspect, Mr. Chairman, we are going to move into 

that mode eventually where we will discuss those proposals, and that is a 

proposal to put on the table and discuss. 

DR. HENNINGFIELD: I am not sure that is an issue right now, but so, you 

would not object to that concept? 

DR. DEBETHIZY: I would not object to putting that proposal on the table 

because my understanding of what this panel is supposed to do is to make 

recommendations like that for serious study and consideration. 

DR. FREEMAN: Dr. Cohen? 

DR. COHEN: Let me just say that a lot of the discussion proceeds from 

what experts know about the FTC method and what it was designed to 

do. I think the real question is what consumers think the numbers mean. 

So, the important issue is how do consumers understand these numbers, 

and I think it would come as a shock to them that these are only to be taken 

as rankings. That would come as a great shock, and I think we should keep 

that in mind. 

DR. TOWNSEND: That is a point, Dr. Cohen, where we clearly disagree. 

DR. COHEN: Do you have any data that show that consumers only think 

about these numbers as rankings? 

DR. TOWNSEND: It is clear to us that consumers look at tar information; 

they also look at the category of cigarettes they smoke, whether it is a light 

or an ultralight or regular, and they make decisions in the marketplace. The 

actual fact is that in the market, sales-weighted tar and nicotine yields have 

declined dramatically over the years, and people have traded taste to do that. 

DR. COHEN: Let me say, in response, that that is perfectly consistent with 

consumers believing that these are real numbers, not rankings. Your scenario 

fits a situation in which consumers think that by going down to a very-lowyield cigarette that these are cardinal numbers and real numbers. I am asking 

you whether your company or any cigarette company has data that indicate 

that consumers only think about these as rankings. The answer is either yes 

or no. 

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Smoking and Tobacco Control Monograph No. 7 

DR. TOWNSEND: It is clear to us from talking with consumers that they 

understand the notion of tar and nicotine yield, that they make choices in 

the marketplace. I am not about to talk about our consumer information at 

this point. I am not a marketing expert, but it is clear to us that consumers 

use the information from the FTC test method in one form or another, and 

even in your words, some use the numbers, and yes, those people who 

actually use the quantitative numbers may be more skewed to the ultralight 

category, but consumers do use the numbers or they use the category 

rankings of cigarettes, whether it be ultralight or regular. 

DR. FREEMAN: Dr. Petitti? 

DR. PETITTI: I am intrigued by the EPA mileage analogy and also by the 

water heater analogy, but I think the difference is one about consumer 

information. When you drive your 38-miles-per-gallon EPA-rated car, you 

know as you drive, based on measurements that you can make, whether or 

not you are, indeed, getting 38 miles per gallon or 19 miles per gallon based 

on your mileage, the way you actually use that car. Similarly for your water 

heater, you get your bill every month, and you can tell whether or not you 

are exceeding or not exceeding the conditions that are printed on your label. 

How does the cigarette consumer know whether or not they are or are not 

getting what is on the package? 

DR. TOWNSEND: I think the point of the analogy is not exactly where you 

are coming from. The point of the analogy is that consumers do not expect 

to get exactly that EPA gas mileage. I know I do not because yes, you are 

right, I can measure it, and I do not, but I do use the EPA gas mileage 

numbers to a degree in making choices in the marketplace in helping guide 

my purchases. I said yesterday that I recently bought a new hot water heater. 

I used the energy efficiency rating in helping me make that choice, and I 

actually paid more for a more efficient hot water heater, but that tag also 

said that the average price or the price you would expect to pay for running 

this hot water heater is $358 per year. Do I believe that is what it is costing 

me? No. So, it is a matter of providing me guidance for making choices 

and in no way do I believe that represents an absolute number that predicts 

my power bill. 

DR. PETIITI: I think you already answered this question, but I do think that 

both for the EPA mileage example and your water heater, and perhaps also 

for cigarettes, that it would be useful to the consumer to know the specific 

range that they might expect under certain specified driving conditions and 

perhaps we are going to get to that in terms of the proposals that we 

consider. 

DR. TOWNSEND: And I believe that is a question on the table because the 

FTC test method was not intended to do exactly that. 

DR. PETITTI: Can you explain to me just once again your view of what the 

FTC method was meant to do in the context of health? You keep saying that 

it was not meant to do that. I am having a hard time understanding your 

view of what it was meant to do. 

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Section I1 

DR. TOWNSEND: Consumers responded to the calls for reduced-healthrisk products for reduced-tar products that were made by the Surgeon 

General, Wynder and Hoffmann, and other members of the public health 

community. Consumers responded to that information, and they demanded 

of the industry a reduction in tar and nicotine yields from cigarettes. A 

standardized comparative, accurate, and reliable test method was required 

to accomplish that, and that was the purpose of the FTC method, to provide 

those comparative data. 

DR. PETITTI: So they could make decisions about health? 

DR. TOWNSEND: So they could make decisions about tar yields in the 

marketplace, which they were told by the public health community were 

related to health. 

DR. KOZLOWSKI: I think there are great concerns about how many 

consumers are getting the information about tar and nicotine yields as they 

exist now. I think at the last testing, the Federal Trade Commission reported 

tar and nicotine yields on upward of 900 cigarettes. According to the rules, 

the tobacco industry is not required to print tar and nicotine yields on 

cigarette packs. They are only in ads. What, in fact, is the percentage of 

cigarettes that are not advertised at all so that there is, in fact, no way for 

the consumer to know? I think that may, indeed, vary from manufacturer 

to manufacturer, but also in a related point some data have shown that 

it is on the ultralow tars that people are most likely to know the yields. 

It is also the fact that it is on the ultralow tars that the yields themselves 

are likely to be printed on the packs. Does the FTC know what percentage 

of brands are unadvertised and therefore consumers have no access to 

information on yields? 

MR. PEELER: We do not have those data, but we can get them for the panel 

if they like. 

DR. FREEMAN: Dr. Shiffman? 

DR. SHIFFMAN: I take it in a sense that we have a significant degree of 

consensus. I have heard the gentlemen from R.J. Reynolds say that they 

would be sympathetic to proposals that would provide more information for 

the consumer to make informed choices, and so, accordingly, I suggest that 

we shift from a mode of asking questions of them to a mode of considering 

proposals that would accomplish that goal on which we seem to have some 

consensus. 

DR. DEBETHIZY: Mr. Chairman, it might help if Mr. Peeler would clarify 

what the purpose of the FTC method is. I think there has been some 

confusion here. I know I have been asked 10 times what the purpose is, and 

if you do not mind doing that, I think if you could do that concisely, that 

would help. 

MR. PEELER: I would go back to the statement that I started with yesterday, 

and that is to say that the purpose of the FTC rankings when they were put 

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together was to establish a comparative basis for consumers choosing among 

cigarettes. The reason the Commission asked the National Cancer Institute 

to commence this review of the cigarette testing methodology was to review 

whether that approach is still the correct approach, and obviously we are 

very interested as an agency in the types of questions that Dr. Cohen’s 

research raises, which is how consumers actually use and view these data. 

DR. FREEMAN: Mr. Peeler, is it implied in what you said that the FTC was 

ultimately interested in what was happening to the American public in terms 

of health? Is that implied in what you say, or was it separate from that or 

were you as an agency concerned about what is happening to the American 

people? 

MR. PEELER: If you look at the history of the establishment of the current 

tar and nicotine testing system, it was clearly driven by concerns about 

health. It was clearly driven by the Surgeon General’s findings that were 

valid at that time, that lower tar, lower nicotine cigarettes had a health 

benefit for consumers. So, clearly one of the issues that the Commission 

asked this panel to address is whether those health considerations are still 

valid in light of research that has occurred since the 1981 Surgeon General’s 

report reviewed those issues and reported them. 

DR. FREEMAN: So, then we would conclude that there is a clear connection 

in the work of this committee, not only to measure appropriately what 

cigarettes contain, no matter what method is used, but the end result that 

we are looking for is how can we help people in America with respect to 

avoiding disease and death, which means we would have to communicate 

appropriately to them in order to accomplish that. Is that a fair statement? 

MR. PEELER Most of the data that I have looked at indicate that there is a 

large group of consumers who are concerned about tar and nicotine ratings 

because of health reasons. So, clearly if the tar and nicotine ratings are 

communicating that to consumers, the FTC would want to make sure that 

these numbers are accurately delivering that benefit to consumers. 

DR. TOWNSEND: Mr. Chairman, I think I am confused at this point because 

what I just heard is different from what I heard in your opening statement, 

and so I pulled out the copy of your opening statement, which says, “The 

primary purpose of this meeting is not to redesign the FTC testing protocol 

but rather to examine the protocol and make suggestions for improvements, 

if warranted.” Your opening statement does not really go to actual changes. 

DR. FREEMAN: You failed to go far enough in the opening statement. We 

posed three questions, the third of which dealt with what I was just speaking 

of, in other words, how does this translate to the American public in terms of 

their perceptions in the opening statement. 

DR. TOWNSEND: Thank you. 

DR. DEBETHIZY: I have a question for Mr. Peeler on the relationship 

between the FTC and the Surgeon General’s warnings. Could you clarify 

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that relationship for me? I was just curious about that because the questions 

that have been asked of me and that we have been getting into are the health 

implications of FTC numbers, and I was just curious about whether the FTC 

method is there to clarify the Surgeon General’s warning, or is it related at 

all, or are they just two completely separate issues? 

MR. PEELER: The FTC method as it was conceived and implemented was 

designed to provide consumers with comparative information about the 

relative tar and nicotine content of cigarettes. We know from the studies 

that we have seen that some groups of consumers look at those numbers 

as indicating a health benefit, which is why the Commission has asked 

the panel to look at the question of whether there is, for example, a doseresponse relationship between the FTC tar and nicotine ratings and specific 

smoking-related diseases. 

DR. SHIFFMAN: Let me come back to what I consider to be items of 

substantial consensus and maybe that will help us move on. I have not 

heard anyone speak against providing the consumer with more information, 

and so it seems to me that the appropriate education of the American 

smoking consumer is something we can all agree on, and that it is part of the 

intention of the ETC system, to give the consumer appropriate information. 

It seems to me that an important aspect is providing appropriate education 

to the consumer about the meaning of whatever information is conveyed in 

this labeling. 

The second item on which I think we have considerable consensus is 

that in human smoking of particular cigarettes there is a considerable range 

or variability in what the consumer will actually extract from the cigarette. 

That was seen not only in some of the talks from past studies but also in 

the R.J. Reynolds study. So it seems to me the second item of substantial 

consensus is that no single number can completely represent the true 

human yield from a cigarette. Therefore, it seems to me that the direction 

in which we should be trying to move is to represent to the consumer the 

sense of that range in variability and to accompany that with appropriate 

educational measures so that we are providing the consumer with the kind 

of information on which to make informed choices, and I think that is the 

basis on which we ought to go forward. 

DR. FREEMAN: Dr. Cohen? 

DR. COHEN: Dr. Shiffman, could I ask if you would be willing to modify 

your view just a bit? I think that to start exactly at that point is not the right 

place to start because I think consumers want to know two things. They 

want to know if I smoke at all, how risky is it, and does that level of risk vary 

with the kind of cigarette I smoke. They want to know that. Now, that may 

be impossible to provide. That is not my field, but they do want it. We 

cannot finesse that issue. 

DR. SHIFFMAN: I quite agree with you, and I think that part of what might 

go into an educational campaign would be about the meaning of these 

numbers or ranges in relation to health outcomes. 

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DR. COHEN: But it begs the question: Is there a way to provide two types 

of information, either in advertising or on the cigarette packages or both? 

The first type is the level of risk for that particular kind of cigarette or the 

level of harmfulness, and the second one is, can we give them a better sense 

of the relative magnitudes? I do not know the answer to either question, 

but I think that if we are going to wonder what we can do to help consumers, 

I think we should think long and hard about the need for those two different 

pieces of information. 

DR. FREEMAN: At this point we are going to shift gears a little bit and get 

into the essence of the deliberations, and we thank the members of the 

tobacco industry for receiving those questions. We will go to the next phase 

of this discussion, which is the main phase and that is, as you remember 

from yesterday, we posed three questions that we were supposed to answer 

during these deliberations, and we are going to look at each of those three 

questions and get your comments on each one. 

Question 1. Does the evidence presented clearly demonstrate that changes 

are needed in the current FK protocol for measuring nicotine, 

tar, and carbon monoxide, and if so, what changes are required? 

DR. GIOVINO: A lot has been made in this conference of the trends over 

time in the FTC yield in terms of tar and nicotine with a very large decline 

between the 1950’s and 1980, roughly, and then a leveling off, and from the 

data that have been presented at this conference, I have to wonder, especially 

given Dr. Guerin’s comments, what would that curve look like if consumer 

changes in puff frequency, puff volume, hole blocking, and vent blocking 

were incorporated? Dr. Guerin and Dr. Zacny have shown that the yields can 

be changed, given various factors, and I see that trend as a measure of yes, 

a standardized measure, but one that may not be as relevant now as it was 

40 years ago. 

So, I have to ask the panel to consider in its deliberations the issue of the 

usefulness of those trend data, given as was demonstrated yesterday the wide 

range of products now available and the different degrees of compensation 

that can happen with those products. 

DR. TOWNSEND: May I respond to that? I believe that the trends that 

you saw yesterday in the chart are useful today as they always have been. 

One thing that I think there is consensus on within this panel is that if 

you change puffing conditions, what you do is shift the tar and nicotine 

yields up or down depending on to what level you change those puffing 

conditions. Even if you block the vents, you shift the tar and nicotine yields 

up, but in general the relative ranking does not change. If the relative 

ranking does not change, you are only changing the absolute values. Then 

that is going to have no substantive effect on the trend charts that showed 

nicotine and tar yield decreases over the years. 

DR. GIOVINO: I have to wonder, given the situation 40 years ago when tar 

and nicotine levels were so high, if those behaviors would have been so 

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common. The relative rankings may be accurate for any given year, but the 

range was so different 40 years ago than it is now that the actual amount of 

some of the compensatory behaviors may have been much less frequent 

40 years ago than now. 

The range in tar values and nicotine values was so much higher in the 

1950’sand the 1960’s given the FTC yield that people may not have had to 

perform the compensatory behaviors and wouldn’t have even had the ability 

to hole block because it is my understanding that there were no holes then. 

So, my concern is that those trend data, while representing what the FTC 

has presented, are not representing even what the consumer is taking out 

of the cigarette, let alone getting into their lungs. 

DR. GUERIN: I am not sure that was ever the case anyway. In trend data, 

what you are looking at are the characteristics of the average cigarette, not 

how the cigarette was used, and that is all those data mean. 

DR. GIOVINO: Exactly. I think the panel understands this, that the trend 

data represent what the FTC method gives. The reality is that trends over 

time in terms of what the consumer is taking out are quite different. 

DR. BOCK: At the very earliest time that yield data were collected, the 

standard deviations were given, which had big meaning for the analysts 

but obviously did not have much meaning for people out in the street. 

But the variability of smoking, which is part of the fact that people in the 

street really need to know, the range of values for each cigarette, has not 

been provided by the data. The labeling might have incorporated that 

type of information, which would in large part, I think, answer some of 

the criticisms. 

DR. FREEMAN: Before you go on, let me follow up on that. Are you 

suggesting then that might be a change in this Question 1concern? 

DR. BOCK: It would indicate that maybe there should be a change in the 

protocol and the way the data are collected, and there should be provision 

made for a range. 

DR. FREEMAN: Measuring the same elements but giving the range. 

DR. BOCK With different smoking parameters. 

DR. FREEMAN: That is a point of discussion. Dr. Woosley? 

DR. WOOSLEY: I think in answering that first one I have to agree with 

Dr. Giovino that things have changed over the years, and I think that is 

what the FTC is actually asking us. There was this huge range of difference 

30 years ago or so, and the ability for this method to predict something was 

great then, but now that most of the tobacco products have come down to 

some very homogeneous group, the variance is quite tight, and the ability 

of this numerical ranking to have any meaningful information or carry any 

meaningful information to the public is gone, in my estimation. Data 

yesterday were very convincing for me that numerical ranking does not 

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Smoking and Tobacco Control Monograph No. 7 

really convey the exposure that occurs because of compensation. So, to me 

the answer to the first question is pretty clear. The current system must be 

changed in some way. 

DR. TOWNSEND: I do not understand your comment that cigarettes today 

are a more homogeneous group. From the data I showed yesterday the 

spread in tar deliveries in 1954 was really quite narrow. Cigarettes were 

really quite similar then. Today there is a huge range of products available 

to the consumer. I see that as less homogeneous. 

DR. WOOSLEY: I was referring to the potential range of intake, not the range 

that the tobacco industry provided us. 

DR. RICKERT: One of the things that people are concerned about is the fact 

that consumers tend to misinterpret the information. One of the ways of 

coming to grips with this problem is to deal with a range of potential values 

rather than specific numbers. This problem was first noted, I think, back 

in the 1981 Surgeon General’s report when at that time there was a call for 

publishing maximal values in addition to the values that are obtained under 

FTC methodology. A more recent paper in 1994 has called for the same 

approach, and I think serious consideration should be given to this question 

of range, how one might express these upper limits, and if maximum were 

to be used, how that maximum would be determined. 

DR. GUERIN: If one examines Question 1that we are addressing, the 

question says, “Is there any evidence that changes are needed in the current 

FTC protocol for measuring tar and nicotine and CO?” I have not necessarily 

seen much evidence for changes in measuring it, but a lot of reasons for 

changes in how we communicate it. Do we have to change the testing 

protocol to achieve this, or do we have to have a better way of 

communicating? 

DR. WOOSLEY: It says, “Constituent yields,” and I think the yield from that 

method is probably inadequate. We need data on the yield to the smoker. 

DR. ZACNY: I just want to go back to something that Dr. Townsend said 

about 5 minutes ago and that we spent some time on yesterday when he 

showed charts where you increase puff volume from, I guess 35 to 55 mL, 

and the relative rankings would not change if puff volume were increased 

across the different yields. I think things change when you talk about filter 

vent blocking and maybe altering parameters for extensive filter vent 

blocking because there is a fundamental difference between lower yield 

cigarettes and high-yield cigarettes. 

The high-yield cigarettes do not have filter vents, and so you could, 

by manipulating this parameter, turn a low-yield cigarette into a high-yield 

cigarette; the relative rankings then would not be preserved. 

DR. FREEMAN: Dr. Rickert? 

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DR. RICKERT: I think there is one issue that we have not really looked at, 

and that is, there is something else that happens when you move from 

standardized FTC testing conditions to other testing conditions. We always 

consider what happens to the quantity of particulates, like tar, for example; 

what should be also considered is what happens to the qudity of that tar. 

For example, in the Brown and Williamson documents that I received, it 

seemed that moving from standard conditions to behaviorally defined 

conditions resulted in an increase in mutagenicity of the tar fraction on a 

gram-per-gram basis using the salmonella assay, and so I think focusing 

totally on the changes in the relative ranking misses the point that the 

biological activity on a per-gram basis may be changing as well. 

DR. FREEMAN: Dr. Henningfield? 

DR. HENNINGFIELD: I would like to follow up on a point that Dr. Woosley 

made. I agree. My impression is that what people want to know is what gets 

into people, not into machines. There is only one way to do that, and that is 

to do what you do with any other drug: Test what gets in people, and that is 

the only way that you can validate the upper range. There is no way you can 

do that with a machine. You have to put the system in people to see what 

they actually get. 

Also, I think you need to do that because as we have seen, with almost 

any system you come up with, the industry might come up with a creative 

way to beat that machine. Testing in humans is essential. The question for 

Dr. deBethizy is, when we were discussing providing a wide range of values, 

and there seems to be some leaning that that would be a useful thing to do, 

you seemed to agree that was worth considering, but that the FTC method 

was not up to that task. I think that is what you said. If that is what you 

said, why is the FTC method not up to the task? 

DR. DEBETHIZY: I did not say that. What I said was that it seemed like a 

reasonable proposal to put on the table. I did not say anything about not 

providing the FTC number. I think the FTC number is a good number. It 

has been a standardized number we have used for a long time to provide 

relative ranking. If somebody is proposing that a range also be determined, 

with a low and a high end, then let us discuss that. 

DR. SHIFFMAN: Let us, indeed, discuss that. It seems to me that the FTC 

assay method may be adaptable to this goal in the sense that if one looked 

at a different set of parameters, if one included the potential vent blocking 

as part of a protocol for maximum extraction or maximum yield, perhaps it 

would be possible to use the machine testing method to adequately describe 

or estimate the range of human exposures from a particular cigarette, and 

that could well be more informative to smokers. 

DR. FREEMAN: Before we get other comments, that seems to be a recurrent 

point of discussion about the range being an important point to consider as 

a possible suggestion, and I would like to zero in on that particular point and 

discuss it. Is there anyone who wants to discuss that point? 

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Smoking and Tobacco Control Monograph No. 7 

DR. KOZLOWSKI: A number of the studies in the literature argue that 

the rankings would be preserved if you had a heavy smoke setting on the 

machine. I think if you consider Zacny’s data and other data, the idea of 

tuning every cigarette up to the same maximum puff volume or maximum 

puff rate is probably not a good model of human smoking behavior; the 

higher yield cigarettes may, in fact, be undersmoked relative to the lower 

yield cigarettes. Zacny’s data on the puff volume show clearly that the puff 

volumes are bigger on the ultralights than on the higher yield cigarettes, so 

that when you have studies that just tune everything up, and you see the 

ranking preserved, the fact of the matter is that if the human behavior is 

more appropriately modeled you may well see that some of the higher yield 

brands go down, the lower yield brands go up, and it would get a lot flatter 

than simply jacking up all the settings of the machine regardless of what the 

strength of that cigarette is to begin with. 

DR. FREEMAN: I think perhaps the question and my own opinion as I am 

posing it, given a particular cigarette, would be what is the range of possible 

exposure of that cigarette compared to any other cigarette? The question 

I would like some consideration of is, is that a reasonable thing to measure; 

is that a reasonable approach to take as to what we should measure? 

Dr. Benowitz? 

DR. BENOWITZ: I think that is a reasonable approach. I think 

Dr. Kozlowski’s point of view is very well taken, but I think in practical 

terms it really is impossible because you would have to study large numbers 

of people smoking every single brand of cigarettes to be able to get individual 

parameters. We know what he says occurs. It seems to me that the idea of 

having the standard condition and an intensive smoking condition with and 

without hole blocking would be very useful, but what it has to be coupled 

with is information for consumers about how their smoking of the cigarette 

will influence the yields. For example, if they block, this is what is going to 

happen, and if they puff intensively or take a lot of puffs, then this is what 

is going to happen, and I think that would be the best we could do to say, 

“If you smoke in this way, you are going to get the maximum yields.” And 

that way we could pick what we think would be an intensive condition and 

say, “If you smoke in this way, this is what your yield is going to be.” 

DR. FREEMAN: With a given cigarette? 

DR. BENOWITZ: With a given cigarette, because I do not think it is feasible, 

although I would like to, either to measure puffing parameters for every 

brand of cigarette or even, as Dr. Henningfield suggested, to do human 

exposure studies if you have 900 brands of cigarettes. I do not think that 

would be practical. I think we should test maybe some brands of cigarettes 

to see how well we are doing, but I do not think it is going to be feasible for 

all these brands to do anything other than a standardized testing. 

DR. FREEMAN: Putting that forward as a point of discussion, does anyone 

disagree with what Dr. Benowitz has said, that we should perhaps 

206 
recommend that a given cigarette should be tested to see what its range of 

possible exposure would be using whatever techniques make sense; is there 

any disagreement with putting that forward? Dr. Hoffmann? 

DR. HOFFMANN: I think that Dr. Benowitz’ old studies concentrated on 

nicotine, but I think when we test on humans and try to see how they 

smoke, we should not limit it to nicotine. There are other carcinogenic 

toxic agents, and I think that the work done by Dr. Benowitz on nicotine 

is outstanding, but it is nicotine, and when we deal with cancer, at least, 

that is my area of expertise, there are agents that are just as important. 

DR. FREEMAN: I did not understand that you were speaking only of 

nicotine. Were you not speaking of tar and the three things that are 

mentioned? 

DR. BENOWITZ: Yes, in terms of the machine testing I was certainly 

speaking of all. In terms of human bioavailability testing, I think as 

Dr. Hoffmann says, if we have tools to measure tar exposure, we definitely 

should do that. Right now the only practical tools for large-scale studies 

are nicotine and CO, but when we get tar measurement tools where we can 

do it on hundreds of people, that should be included. 

DR. TOWNSEND: If I could respond, my reaction to your proposal is that 

if we provide to the consumer an ETC number and a maximum deliverable 

number by hole blocking and a more intense puffing regimen, which I 

believe is your proposal, then from what I know about cigarette design those 

two are going to very closely parallel each other, and the ranking of cigarettes 

will be largely preserved. My question then is, does that provide additional 

and useful information to the consumer? 

DR. BENOWITZ: I would like to respond to that. I do not believe that 

the ranking will be preserved. If you have the old-style cigarettes that are 

nonfilter cigarettes, no matter what you do, the ranking is going to be 

preserved, but if you are comparing a nonfilter cigarette and then a cigarette 

that has extensive ventilation and you block holes, you might see one 

surpass the other. I just do not believe that when you are dealing with a 

cigarette that has 90 percent ventilation in a standard test and people have 

the possibility of reducing that to zero percent ventilation, and you are 

comparing that to cigarettes with no ventilating filters, the ranking will 

be preserved. 

DR. TOWNSEND: As a cigarette designer, I believe that it will be largely 

preserved, and I guess what I am hearing you say is that this is your 

suspicion, but I guess my question, is do you have data that support that, 

and I guess the obvious direction I am going in with this question is, should 

we collect data to see whether the ranking is largely preserved to convince 

you? 

DR. FREEMAN: I think we have a question over here. 

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Smoking and Tobacco Control Monograph No. 7 

DR. HATSUKAMI: You mentioned changing the intensity of smoking. 

I would like to know how you determine those parameters; how do you 

determine the number of puffs that should be taken, the range of puffs that 

should be taken, or the volume that should be taken; what should that be 

based on? 

DR. BENOWITZ: I have not looked at the current studies to see what is 

available, but I think you could do that on the basis of looking at 

observations, say in people who are smoking low-yield cigarettes and seeing 

what they do. 

DR. HATSUKAMI: With the minimum and the maximum ranges in terms of 

number of puffs? 

DR. BENOWITZ: I do not think a minimum is really necessary. I actually 

believe that we should continue to report the standard FTC method mostly 

because I would like to know how current cigarettes compare to cigarettes 

marketed 20 years ago so we could have that as sort of a minimum because 

in fact, you know, it is my belief, based on the evidence, that for the vast 

majority of cigarettes the FTC method underestimates exposure. So, we 

could still have that as a minimum exposure, and then we could have the 

test method to show what a smoker might get if they smoke in an intense 

way, which could then be specified. 

DR. FREEMAN: Dr. Bock? 

DR. BOCK: It does not make a lot of difference to me whether the 

ranking is changed or not. When you put down an average and a standard 

deviation, sophisticated people can understand whether the differences in 

the average are important, and a range will give that kind of information 

to unsophisticated people, and that is where I think the big advantage of 

a range is. Whether it changes the ranking, it will say that if the cigarettes 

are very closely ranked one above the other, it really does not matter very 

much which is the reality of the situation. 

DR. FREEMAN: Dr. Hughes? 

DR. HUGHES: You asked if there is any disagreement. I have a little bit of 

a disagreement, in that I am still worried about reporting numbers. I could 

go along with numbers if there were a disclaimer that says that 10mg of 

tar does not cut your risk in half compared to 20 mg of tar. I am still very 

concerned that even if we give ranges that people are going to look at the 

averages and think that 10 gives you half the health risk of a 20, but it does 

not. 

DR. FREEMAN: Dr. Hughes, what would you recommend in that case? 

DR. HUGHES: You could go with either the nonnumerical system where 

you certainly had a band and put them in or numbers as long as there is a 

disclaimer that these are not cardinal numbers. That can be communicated 

fairly easily by doing that. 

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Section II 

DR. FREEMAN: So, you favor going with numbers or not going with 

numbers? 

DR. HUGHES: We have a long morning ahead of us; I can be persuaded either 

way. My only point is there must be some information to the consumer that 

10 mg is not half the risk of 20. As long as that is in there, I am agreeable. 

DR. FREEMAN: 1 think it is conceivable that whatever we decide here could 

also be accompanied by something in writing to explain and educate the 

public. I think we should assume that could be done. 

DR. HUGHES: I would like to see if maybe Dr. Shiffman or Dr. Benowitz 

could give us a more concrete proposal here to make sure that we know what 

is going on because what I hear people saying, and I just want to make sure 

we are all saying the same thing, is that having a testing method that has a 

range of values, 1 do not know whether you want to call it the 95 percent vs. 

the 5 percent or something like that, some range of values based on doing 

different things, blocking holes and that sort of thing, but we are also talking 

about one thing (I was unclear), is still reporting a mean or not reporting a 

mean? That is what I am confused about. 

DR. SHIFFMAN: You are suggesting that the current FTC system would 

represent a band? 

DR. HUGHES: So, not a range. So, is it from the 50th to the 95th percentile? 

DR. BENOWITZ: I do not think the current FTC is the 50th. 

DR. DEBETHIZY: Yes, I do not think we want the current FTC method to be 

the bottom. I mean if you are talking about a range, the range has a low and 

a high, and the FTC number is in the middle. So, I think that is important. 

If you are going to talk about a range, you have to talk about the whole range. 

DR. HUGHES: I think you have to have a range, but whether the FTC ends 

up in the middle I do not know. Let me suggest that I do not think that just 

getting an upper and a middle is fair to the consumer because there are 

consumers at the lower end who are getting more health benefit, if there is 

any, from the low-yield cigarettes than the average smoker, and I do not think 

it is fair to not portray that to them. So, I would like to see the full range. 

Everybody thinks they are the average. I would like to see it not 

have a mean. 

DR. FREEMAN: Dr. Cohen? 

DR. COHEN: I would guess that I am thinking ahead to what might happen 

in the marketplace, both competitively and with respect to smokers who are 

also consumers. I think that we have to understand that whatever analysis 

is done for internal purposes among specialists is one thing, but when 

information is presented to consumers in a form that they cannot handle, 

we cannot underrate the difficulty of educating them about that. It is not 

going to be easy to explain the idea of a range to consumers. I would ask 

the panel to consider a slightly different alternative, and that would be to 

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Smoking and Tobacco Control Monograph No. 7 

vary the test parameters and produce a range of reasonable smoking 

responses on say, tar, maybe using the machine and then to pick some 

number like the mean plus a standard deviation, let us say, just to throw 

something out for discussion, because this would represent a number that a 

reasonable number of smokers might really encounter. In other words, that 

would be the tar level that a substantial number of smokers would actually 

encounter in smoking a cigarette, and if that were presented to consumers, 

yes, it would err a little bit on the high side for some consumers, but I think 

our duty may be to give consumers information that serves to protect a 

reasonable number of those who are ingesting more. 

I think that if that number were provided, I do not want to call it a 

maximum, you would find that firms would have an incentive to modify 

cigarettes. They have a lot of design features they can use to modify lowyield cigarettes to be sure that the mean plus one standard deviation would 

be as low as possible, and I do not think we should underestimate the 

importance of what is done here on the design of cigarettes in the future. 

I do not think we should underestimate that, and I think if we give them 

something along the lines of what we are talking about, they have the ability 

to see that their cigarettes come in at as low a number as possible. 

DR. FREEMAN: May I ask you, Dr. Cohen, how would you reach the mean in 

such a method? 

DR. COHEN: I am certainly not technically competent, but in listening to 

the discussions and reading the papers, if the FTC testing method were 

adjusted to deal with such things as puff number, puff interval, and puff 

volume and this were done based on an observation of how smokers smoke, 

just as it was done when the original Cambridge Filter method was set up 

in the first place, then you would be able to know what the magic number 

would be for two-thirds of the sample or some arbitrary number, and it 

would be greater than the mean. I think that number would probably be 

a lot easier to communicate than a range, and it would have the side benefit 

of better informing smokers as to what their potential risk might be, and it 

would also provide great incentives to the industry to make cigarettes that 

came in at as low a number as possible. 

If one of the major problems with the low-tar cigarettes is where the filter 

holes are and how they work and the fact that they can be covered, then if 

this testing protocol were followed and the mean plus one standard deviation 

for that cigarette the way it was smoked were a fairly large range and if the 

company making that cigarette did not like that large a number, it has the 

capability of reducing that number by putting the filter holes in such a way 

that they are not going to be blocked. 

I would say that it is very important to consider the impact of what is 

done here on what they do. 

DR. FREEMAN: Dr. Shiffman? 

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Section II 

DR. SHIFFMAN: I very much share your concern that we come up with a 

system that is communicative and that is grasped by the smokers whom we 

are trying to reach. Part of what is attractive about a range is that it also 

communicates, to borrow a phrase, that their “mileage” will vary. My 

concern about any one number, no matter where you put it on the spectrum, 

is that it does not communicate that and implies that this is exactly what 

this cigarette will deliver. So, I think it is a significant challenge to health 

education, public education, and advertising people to design a system that 

communicates this idea of range and the idea that range is to some degree 

under the control of the smoker and his or her behavior. Part of what is 

attractive to me about that range is communicating exactly that, that the 

human yield is variable and that it is variable to some degree according 

to the behavior of the smoker. That is something I would like to see 

communicated. 

DR. FREEMAN: Dr. Stitzer? 

DR. STITZER: I just want to support that point. I think that we are dealing 

with a situation where the public is very lacking in knowledge, and the one 

particular thing that is not understood by smokers, I believe, is that the 

way they smoke their cigarette determines the yield that they get from it. 

I think the basis of the system we design should be to convey a very basic 

piece of information, and some of these ideas about ranges and so forth 

are important. The fact of the matter is that, with low-yield cigarettes, 

these ranges are going to be very wide. They are going to be completely 

overlapping with the higher yield brands, but that is exactly the information 

that we want the consumers to know. 

Now, the unfortunate part is that consumers do not have any good 

way of knowing where they in particular fit along any range that we might 

present, and that is a different problem. 

DR. FREEMAN: Dr. Benowitz? 

DR. BENOWITZ: I would also like to support Dr. Shiffman’s comments and 

just say that we could be specific about this, and I think we should be. For 

example, we can say that if you block these ventilation holes, this is what 

your exposure will be, and if you do not, this is what your exposure will be, 

and we can also request that ventilation holes be marked to make them 

obvious to the smoker. Make them bright red or orange or something to 

minimize your exposure; I am all for ultralow-yield cigarettes if people will 

smoke them that way. I think that is great. You have to make it possible 

for them to do that, and we could with labeling. 

DR. FREEMAN: Dr. Henningfield? 

DR. HENNINGFIELD: I also agree that the range is basic, honest, accurate 

information, but it is clear that it has to be coupled with education on what 

factors may affect your intake: how consumers can change their behavior 

in ways that might be helpful. But a really important point of Dr. Cohen’s 

I think should be considered, and that is the importance of providing an 

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Smoking and Tobacco Control Monograph No. 7 

incentive to the industry that may serve people. Drs. Benowitz and 

Kozlowski and I had this embedded in our Iournal ofthe American Medical 

Association proposal: the notion that right now, in our estimation, virtually 

all cigarettes you throw into the regular category, but by providing the 

incentive to get that label of low, which could be a really nice selling point 

and may be of health benefit, you would have to work to redesign cigarettes 

in such a way that I think would be useful, and what you would have to 

do is redesign them in a way that would make sure that the upper level was 

lower. And that brings me again to the reason that I think we need some 

bioavailability testing. I agree with Dr. Benowitz, not necessarily on 900 

brands, but you need to anchor it at some point to what people get, and you 

need an agency that can oversee that properly and also require it on demand; 

that is the only way you are going to prevent another Barclay cigarette type 

of scam, the notion that somebody comes up with a design that seems to 

meet the low category, and they have just done it by beating the machine. 

The only way you are going to check that is by seeing what people get. 

DR. GUERIN: Dr. Henningfield, as a good example, the FTC test is what 

discovered the Barclay scheme. The FTC test has been successful in 

identifying those kinds of problems. 

DR. SHIFFMAN: Dr. Henningfield, I take that perhaps as an additional 

proposal that you address a different issue than we have been talking about, 

which is the use of words like “light, low, ultralight” in advertising and the 

importance of making those accurate and not deceptive or confusing to the 

consumer, and that I think is something we ought to address. That the 

information that is presented to the public in advertising goes beyond the 

small numbers printed in the corner to the large “light,” “ultralight,” “low” 

printed in bold print, and I think that is something we ought to look at. 

DR. HENNINGFIELD: Yes, I think those words should be banned. 

DR. SHIFFMAN: I would disagree that they should be banned. They should 

be regulated so that they are accurate. 

DR. FREEMAN: Dr. Rickert? 

DR. RICKERT: I think it is obvious that many consumers choose their brands 

on the basis of some perceived risk to health, and it is also obvious that the 

FTC numbers do not and never were designed for that particular purpose. 

I share Dr. Hoffmann’s concern in that our measure of dose is often based on 

nicotine, which may or may not tell us about other constituents in tobacco 

smoke. Specifically, at the level of molecular epidemiology, there are certain 

constituents that now can be tracked, and Dr. Hoffmann has mentioned 

NNK in urine. There is the constituent 4-amino-biphenyl, which is present 

in tobacco smoke and which in smokers ends up as a hemoglobin adduct. 

There is, also, benzo(a)pyrene, which in smokers ends up being bound to 

albumin. So, there are a number of traceable constituents in tobacco smoke 

that have known toxic or carcinogenic properties, which also then can be 

related to uptake in smokers and nonsmokers alike. 

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DR. FREEMAN: Dr. Cohen? 

DR. COHEN: I would like to return to the point that Dr. Henningfield was 

just talking about and the point that I raised a few minutes ago. I think it 

is very important not to put the burden in the wrong place. 

If we are going to put the burden on consumers to respond to whatever 

design changes industry makes and then educate them each time industry 

makes a clever change, as to where they put the holes or what kind of paper 

they use or whatever, we are fighting a losing battle. I think that the best 

approach here is really to allow the industry, which is able to modify its 

product, to modify it in order to obtain the maximum benefit to their sales 

from a low rating. They have an incentive to do that, and so, if the panel 

deems it appropriate, I would suggest that coming up with a rating system 

that reports to consumers a number within the range, which is not at the 

midpoint of the range but is tilted toward those who do compensate, is the 

smartest thing that can be done because that, in fact, will offer guidance 

to consumers who after all should not have the primary responsibility for 

outsmarting the designers of cigarettes, and 1 think that it would also provide 

the cigarette industry an opportunity to modify their design in order to 

achieve the numbers that are most beneficial for them. 

DR. FREEMAN: Dr. Hoffmann? 

DR. HOFFMANN: Before we got this upper limit and extreme, we should ask 

Dr. Guerin how far we can go. We have heard yesterday that the low-tar 

cigarette smoker may take up to 60 to 65 mL per puff and up to 6 or 7 puffs 

per minute; is that possible with our current equipment? 

DR. GUERIN: Current instrumentation would have to be modified 

somewhat to reach some of the extremes in terms of volumes. 

DR. HOFFMANN: You can do more than 50 mL? 

DR. GUERIN: Right. 

DR. HOFFMANN: With the machine? 

DR. GUERIN: No, I said that you can, but it would require some 

modification. 

DR. HOFFMANN: New machinery? 

DR. GUERIN: To reach some of the extremes in terms of puff volumes, 

frequencies for a 20-port system would be too high. You can purchase 

systems of smaller capacity that have that flexibility. 

DR. HOFFMANN: But the standard machine we have now cannot go 

through these extremes? 

DR. GUERIN: It would not be able to go through all the extremes without 

some modifications. 

213 
Smoking and Tobacco Control Monograph No. 7 

DR. BOCK: The cost of the machine really is not something to use as a basis 

for this discussion. It is so small compared to the cost of labor that it is 

meaningless. 

DR. FREEMAN: Dr. Hughes? 

DR. HUGHES: We have been talking about these numbers and as scientists 

we like to talk about numbers, and maybe we will get to this with the third 

question. My major concern is conveying how much health benefit peopIe 

get by these lower nicotine, lower tar cigarettes because what I saw in the 

1981 Surgeon General’s report and what I saw Dr. Samet present yesterday 

suggest to me that it is not great, and it is not very large, and I think when 

the normal consumer switches to a 1-mg cigarette, they think they are doing 

themselves a great benefit, and my concern is that the magnitude of that 

effect be conveyed to the consumer. 

DR. FREEMAN: Dr. Rickert? 

DR. RICKERT At the present time, FTC methodology is providing us with 

information on tar and nicotine and CO; when we are talking about lower 

yield cigarettes, we tend to link tar and nicotine explicitly together, and 

while there is an obvious relationship between these variables, there is also 

extreme variation. 

All one has to do is take the 933 brands that were just published recently 

in the FTC report and look at various plots of CO vs. nicotine or tar vs. 

nicotine, and you cannot help but be struck by the fact that there is a wide 

range of variation as far as specific nicotine level. 

For example, if you look at that report and brands delivering .9 mg 

of nicotine, there were 54 brands with varying tar yields. So, I think, 

in addition to the issue of tar and nicotine, that the issue of how one 

communicates simultaneously changes in all three variables because you 

can have the situation where it could be high tar-low nicotine or low 

tar-high nicotine, and by constantly linking the two together, I think 

one is missing the point about the other two variables. 

DR. FREEMAN: Yes, Dr. Stitzer? 

DR. STITZER: I was going to pick up on Dr. Hughes’ point because it is 

an important one, but I think it is very much intertwined with the whole 

discussion about reporting of the machine testing yields. If the smoker 

can visualize the fact that the actual yield from this low-yield cigarette is 

completely overlapping with the yield from this other high-yield cigarette, 

then I think that can more easily bring home the other health message, 

which is that switching to these cigarettes may not have any benefit 

whatsoever. I think that there is a dose-response problem there. 

DR. FREEMAN: Dr. Benowitz? 

DR. BENOWITZ: I think that it would be great if we could put something 

in about health risks. I think the data seem very clear that smoking any 

214 
Section I1 

cigarette is so much greater risk than smoking none that it will be impossible 

to quantitate it, and I think that should be communicated. But at the same 

time, even if there is a small difference in exposure from high- to low-yield 

cigarettes, if you are talking about a huge population of smokers, it is 

worthwhile to encourage as many possible to get as low a yield as possible, 

even though it is not going to have nearly the effect of stopping smoking. 

It still is of some benefit. So, I think we should warn people that switching 

to low-yield cigarettes is not going to remove the risk of smoking, but still 

try to encourage that somehow people do that. 

DR. DEBETHIZY: Dr. Benowitz, you are raising an important issue. It is that 

whatever change that gets recommended here today to the FTC,it is going to 

require some research and some study to make sure that some unintended 

things do not occur. For instance, if ranges were recommended, and put 

on in advertising, would that have the effect of discouraging people from 

switching down? As a scientist, I think it is important for us to understand 

the ramifications, and I am assuming that this is just the start of a process, 

that recommendations will be made, and that the FTC will consider those 

using research techniques. 

DR. FREEMAN: Yes, Dr. Shiffman? 

DR. SHIFFMAN: Just to proceed on the point that Dr. Hughes and 

Dr. Benowitz made, we have said a couple of times that the idea of educating 

smokers is very important. I think educating them not only about these 

numbers or ranges but also about the comparative benefit of not smoking 

at all vs. lowering the received yield is an important part, and I think it 

deserves some discussion, though perhaps not here, about the degree to 

which that can be done in this sort of labeling rating system or whether, 

in fact, we need other media as well. There is limited information we are 

going to get on a pack or in an ad, but I think there is a responsibility to 

educate smokers so that they do make those informed choices. 

DR. FREEMAN: Dr. Woosley? 

DR. WOOSLEY: I agree' slightly with the representative from the tobacco 

industry that we have to make sure there are no adverse consequences from 

anything that we try to do in a meaningful way, and one of the most serious 

concerns I have is that we do not want to give a false impression about 

health risks. I think one of the most disturbing pieces of data that I saw 

yesterday was the indication that people who were on the ultralows had 

a lower cessation rate, and I am concerned that potential means that the 

recommendations that come out of this panel may encourage people to go 

to low yield instead of stopping smoking, and I think that overall will be 

a terribly adverse health risk or adverse effect on the overall health of the 

Nation. 

DR. FREEMAN: Yes, Mr. Peeler? 

MR. PEELER: In line with that discussion I just wanted to throw out two 

pieces of information for the panel's consideration. The first is from the time 

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Smoking and Tobacco Control Monograph No. 7 

the ban on tar and nicotine claims in advertising was lifted, the FTC basically 

prohibited any health claims in the advertising. So, what you are seeing is 

really what consumers are inferring from the low-tar and -nicotine systems. 

The other thing that we have focused on and thought about in this area is 

the fact that the Government’s position for many, many years has been that 

people who are concerned about their health should stop smoking. There 

is actually a warning on the packages right now that says that. Stopping 

smoking now increases your health, but it is a very difficult communications 

conundrum, as Dr. Shiffman has indicated, about whether you can talk about 

relative risk from tar and nicotine and not send an unintended message that 

Dr. Woosley is talking about, that this is the better way to go. 

DR. FREEMAN: Yes, Dr. Kozlowski? 

DR. KOZLOWSKI: I think it is pretty clear that smokers currently are turning 

to so-called “light” and “ultralight” brands, believing that they are doing 

themselves a favor with respect to their health. I think there is a real concern 

about health-conscious smokers who want to try to do something. They now 

have the impression: How could a light cigarette kill anybody; how could 

an ultralight cigarette kill anybody, and there is no deadly connotation to 

the terms “light” or “ultralight.” By providing better information the hope 

is that some of the people who out of health concerns are turning to lower 

yield cigarettes will see something of the risks of that, and they may be in a 

fool’s paradise, and they maybe should stop altogether. The pamphlet that 

was passed out in an earlier version about 10 years ago was titled “Tar and 

Nicotine Ratings May Be Hazardous to Your Health: Information for Smokers 

Who Aren’t Ready to Quit Yet.” A smoker who is smoking a 1-mg tar 

cigarette and enjoying it may think, “My God, I am smoking the lowest 

yield cigarette on the market; how could that do me any harm? I have really 

done something.” If that smoker then sees, “I blocked the vent holes,” and 

so on and so on, the hope is that becomes an inducement to stop. I think 

you expressed some reservations about use of the term “consumers,” but I 

think it is important that continuing smokers be treated in part as consumers 

and be given information similar to what consumers have expected about 

automobiles and things like that. 

DR. COHEN: Could I follow up with some numbers? I have some evidence 

exactly on the point that you just made, and it may be useful to the panel to 

hear the evidence. I apologize, again, because you couldn’t read the numbers 

so clearly yesterday. In my survey, 83 percent of those smoking 1-to 5-mg tar 

cigarettes thought that switching from a 20-mg tar cigarette to a 5-mg tar 

cigarette would significantly lower that person’s health risks due to smoking 

for someone who smokes a pack a day. More than 25 percent of those 

smoking cigarettes with 6 or more mg of tar thought that switching from a 

20-mg tar cigarette to a 16-mg tar cigarette would significantly lower that 

person’s health risk due to smoking for someone who smokes a pack a day. 

DR. DEBETHIZY: I would not be surprised at that because the Surgeon 

General said in 1981 that if you reduced your tar intake, you reduce risk. 

216 
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It has been communicated pretty clearly that if you cannot stop or are 

unwilling to stop, then reducing your tar intake is a good idea. 

DR. GIOVINO: I would like the Surgeon General’s comments to be put on 

the record so that they could be stated exactly and hopefully they will be 

used exactly as stated. The Surgeon General said: 

The Public Health Service policy on lower tar and nicotine 

cigarettes must remain unchanged. The health risks of cigarette 

smoking can only be eliminated by quitting. For those who 

continue to smoke, some risk reduction may result from a 

switch to a lower tar and nicotine cigarette provided that 

no compensatory changes in style of smoking occur. 

I would ask that caveat be used when these types of statements are made. 

I would also remind us that while the relative risk studies on lung cancer 

may have controlled for number of cigarettes a day, and I am not sure of the 

methodology on those, they certainly have not controlled for changes in puff 

frequency or puff volume. So, one point I want to make is, let us make sure 

that we provide in any statements we make about the Surgeon General’s 

statements the caveats that the Surgeon General’s report provides, and the 

second point I would like to make is that the categorization of light and 

ultralight cigarettes in advertising and promotion is not always consistent. 

There are many exceptions to those rules that Ron Davis pointed out in his 

article in the American Journal ofPubZic Health, and the current system of 

light and ultralight seems not totally consistent at times with the tar and 

nicotine ratings. 

DR. FREEMAN: Dr. Headen? 

DR. HEADEN: I want to go on record in support of the color-coded 

representation of the FTC information for the consumer and to go on record 

in support of a range rather than a single number. I would ask us to consider 

the point that Dr. Cohen made. It is important to design this information in 

a way that would encourage the tobacco industry to redesign cigarettes to 

conform to whatever standard we adopt, but I do believe that if there is a 

range that there will be an incentive on the part of the industry to lessen the 

width of that range. A cigarette brand that has a very broad range gives a 

very clear message to the consumer that the yield is variable, particularly 

when they consider the upper limit, and that there would be a high incentive 

for the industry to narrow the range of whatever yield there is for each of the 

cigarettes. 

DR. FREEMAN: Thank you very much. Because we have two other major 

elements to consider today, and it does not mean we cannot discuss more 

of this, we want to go to the second question, and you can continue to raise 

ideas on the first question as we go along because they do overlap a bit. 

217 
Smoking and Tobacco Control Monograph No. 7 

Question 2. Should constituents other than tar, nicotine, and carbon 

monoxide be added to the protocol? 

Dr. Henningfield? 

DR. HENNINGFIELD: I do not think we have the information to decide the 

entire list, but we probably have some ideas of things that should be added. 

I would suggest that the procedure be used as the FDA uses for food labeling, 

which is that substances that an organization or committee with specialty in 

toxicology agrees are of toxicological significance be added. And with foods, 

under the category of other flavorings and ingredients, industries are not free 

of listing things that are of toxicological significance just because they call it 

a flavoring, as occurs with cigarettes. Rather an outside body decides what is 

of toxicological significance. I do not know if they are of toxicological levels, 

but that should not be decided by the tobacco industry, in my opinion. That 

should be decided by a regulatory agency with toxicology experts. 

DR. FREEMAN: Dr. Benowitz? 

DR. BENOWITZ: I think Dr. Henningfield’s comments are well taken, but 

I would just like to go on record in support of the sort of labeling that 

Dr. Harris showed us yesterday, which I thought is very informative to 

consumers when you see all the cyanide and arsenic and all those things in 

cigarettes. I think it just helps to provide more information to a consumer 

about the mix of what is in their tobacco smoke. I am sure they are not 

going to read every bit of it, but anytime they are interested in looking and 

they see a list of 30 cancer-causing compounds, I think it is useful for them 

to know that. So, I am in favor of having that sort of listing available. 

DR. FREEMAN: May I try to understand what you said, that you would not 

present measurements in the way that we are measuring the three elements, 

but you would simply list them as carcinogenic or harmful to health? How 

would you do this? 

DR. BENOWITZ: I think you could do it either way. It would be relatively 

straightforward to measure those and just list how many micrograms or 

whatever was there, or you could just list them. I do not have a very strong 

feeling about it just as long as it is made clear to people what the types and 

the mix of toxic chemicals they are taking in their smoke. 

DR. FREEMAN: What I mean is, you would treat them differently from the 

way we are treating tar, nicotine, and carbon monoxide? 

DR. BENOWITZ: Yes, I do not think we need to provide information about 

standard and maximum exposures, for example. I just think if we had one 

number or one list it would be adequate. 

DR. FREEMAN: I see. Thank you. Dr. Rickert? 

DR. RICKERT: I think there should be additional communication of 

information. I question whether or not it should be in the form of an 

absolute number. For example, it could be categorized in terms of 

218 
Section II 

ciliatoxic agents and hydrogen cyanide, for example. It could be categorized 

as carcinogens and then certain carcinogens. I think, given all the 

discussion that we have had both yesterday and today about the potential 

misinterpretation of numbers, it would seem to me that to add to that 

confusion by a whole new set of numbers would not be serving the interests 

of the consumer. 

DR. FREEMAN: Thank you, Dr. Rickert. Dr. Stitzer? 

DR. STITZER: I am totally in favor of more information being given to the 

consumer, but I want to bring up priorities and to point out that cigarette 

packs are not very big, and personally I think it is more important to convey 

the information about the variability of yield in some prominent way on a 

cigarette package rather than using that space to list hundreds of chemicals. 

Now, what I would be interested in seeing is a kind of package insert 

disclosure information that would be put in cigarette cartons. That might 

be a better format for delivering the information. 

DR. FREEMAN: Dr. Petitti? 

DR. PETITTI: I would like to provide support for both of the prior 

statements, particularly that perhaps cigarettes need to have prominently 

displayed the fact that they contain some list of selected carcinogens but 

not to portray that information in a quantitative fashion. I do not think we 

have the ability to decide which of the numerous carcinogens in cigarette 

smoke is the one or the ones that quantitatively are related to the various 

forms of cancer caused by cigarettes and that we would be further misleading 

the consumer by making them believe that, for example, a cigarette with low 

levels of chemical X is better for them than a cigarette with a higher level of 

chemical X. I do not think we will ever have the epidemiological database 

that will allow us to link these various carcinogens quantitatively with risk 

of any of the human cancers. 

DR. FREEMAN: Yes, Dr. Guerin? 

DR. GUERIN: If we had a list of common cigarette smoke toxins on 

packages, would that not discourage the industry from producing products 

that have undetectable quantities? Wouldn’t we need some kind of a level 

of detection to determine when we are at basically nothing because there 

are advanced products that are being marketed or may be being marketed? 

DR. FREEMAN: Let us go to Dr. Hughes first. 

DR. HUGHES: People are interested in function. They do not care about the 

names. They care about what these things do. So, my proposal would be to 

get the word “cancer-forming” agents on there. That is the important thing, 

not whether it is this long name or that long name or whatever because that 

is the important thing that consumers need to know. 

DR. FREEMAN: Yes, Dr. Townsend? 

219 
Smoking and Tobacco Control Monograph No. 7 

DR. TOWNSEND: Thank you, Mr. Chairman. In the U.S. market, cigarettes 

with comparable blends, in fact, show similar ratios of most smoke 

constituents per milligram of tar. What that means is, as you bring the tar 

level down in a cigarette, these constituents also come down more or less 

proportionately. 

I guess the question then that leads me to is, are we providing really 

useful information for the consumer to use, or are we just giving them a lot 

of information that they are going to ignore, like I think Dr. Harris indicated 

that he did not read all the information on the food labeling. There is a lot 

of information there. Is it useful information? That is just a question I am 

proposing. 

DR. FREEMAN: I understand. Dr. Rickert? 

DR. RICKERT: I agree with what Dr. Guerin has said, in the sense that it 

would seem that if there are new products being developed that would have 

a zero yield of various carcinogens or ciliatoxic agents that must be allowed 

for, and I think for that, for the agent to appear on the package, there would 

have to be some consideration given to analytical detection limits and things 

of this nature. So, I do not think it should necessarily be a blanket piece of 

information that comes with every brand of cigarette, but there should be 

some differentiation based on the individual products of the cigarettes. 

DR. FREEMAN: Yes, Dr. Henningfield? 

DR. HENNINGFIELD: There always has to be a threshold for whether you 

list something, whether you are listing the lead in flour or rat droppings or 

whatever it is. So that is a basic concept, but I think the important thing is 

that an agency or panel with expertise, not the industry being regulated, 

make the decision. So if BHT is listed on flour or cookies, you know, we do 

not have to worry about how much of it is in there; I agree, that would be 

confusing, but another group decides if the cyanide should be listed as 

one of the “also contains” ingredients, for example, “also contains cyanide, 

formaldehyde, lead.” You have somebody else decide what is of potential 

significance and therefore should be listed, and that is what is done with 

food labeling. 

DR. FREEMAN: So, in principle what are you saying that we should do? 

DR. HENNINGFIELD: Of course there is a threshold, but that threshold does 

not necessarily affect the labeling on the pack in the sense of the number 

because you are not putting any numbers in the same way that for potato 

chips you are not putting how much BHT is in there. You are listing the 

milligrams of things that groups decide are very important to list by 

milligrams like cholesterol and sodium, and then you have the list of other 

ingredients as Dr. Harris showed on his label, and what the thresholds are; 

to merit listing, another group decides that-a group with toxicology 

background. 

DR. FREEMAN: Dr. Rickert? 

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Section I1 

DR. RICKERT: I am not really quite sure whether it is a toxicological 

consideration or whether it is a chemistry consideration. If you take 

cholesterol, for example, in order to earn a label of cholesterol-free, there 

has to be a certain level. I mean in the instrument you can measure this 

level, but it is cholesterol-free if it is less than that level. So, I think the 

issue, from my point of view anyway is more of a chemical issue, rather 

than a toxicological issue. 

DR. FREEMAN: Dr. Shiffman? 

DR. SHIFFMAN: I would like to come back to an issue that I think we 

discussed but perhaps had not gotten closure on, which is the consumer 

information or misinformation that is conveyed outside the formal label in 

the form of brand names like “light” and “ultralight,” and I guess what I was 

hearing from several people was a proposal that the use of those terms be 

regulated in a manner parallel to the FDA’s recent regulations of such labels 

on foods. That is my own view-that those labels ought to be allowed. They 

have the potential to provide a smoker with meaningful information, but 

they should be regulated so that they represent a particular number or range 

in the ratings and so that they have a common meaning across brands and 

across manufacturers. I would like to hear other people address that issue. 

DR. FREEMAN: Dr. Hughes? 

DR. HUGHES: I think that is a good comment, Dr. Shiffman. Where I keep 

seeing the break is at .5. The ones less than .5 are different from those 

above .5. So I would like to see the categories only be on those that are 

less than .5 mg of nicotine with the comparable tar. 

DR. FREEMAN: I think the general question here is, should constituents 

other than tar, nicotine, and carbon monoxide be added to the protocol for 

testing? It sounds to me as though you have said that they should not be 

added for testing or, if testing is done, it should be done by either chemists or 

toxicologists but not in the same way as for the other three major substances. 

There is a question of whether certain substances should be listed in some 

way on the tobacco pack or in some other way, so the American public 

would know that there are harmful ingredients in tobacco other than the 

three elements. 

Let us try to get closure on that particular point before we go on. 

\ 

DR. GUERIN: I think that tar and nicotine and CO in terms of quantitative 

measurements are adequate. I have one question for Dr. Hoffmann. Of 

all of the constituents that might not necessarily correlate very well with 

tar, the N-nitrosamines stand out. Should we consider an N-nitrosamine 

measurement? 

DR. HOFFMANN: When you find another HCN, benzo(a)pyrene, you will 

always get from our friends of the tobacco industry, “Yes, but this can come 

from air pollution.” Carcinogens that derive from nicotine can come only 

from tobacco, and I think that should be cited. Benzo(a)pyrene comes from 

221 
Smoking and Tobacco Control Monograph No. 7 

every combustion. Hydrogen cyanide comes from every combustion of a 

protein-containing component. Phenol comes from any combustion. The 

tobacco-specific nicotine-derived nitrosamines, which are strong carcinogens, 

come only from tobacco. I think the consumer should know that. 

DR. GUERIN: To my knowledge that is the one class of chemicals that might 

be considered in addition, although it would be very difficult to do, relative 

to tar and nicotine and CO measurements. 

DR. HOFFMANN: I personally do not think we confuse the smoker. I think 

we can let them know on the package that cigarette smoke contains toxic 

agents: hydrogen cyanide and known carcinogens, chloraminobiphenyls, 

benzo(a)pyrene, and the nicotine-derived nitrosamines. We should say that, 

though not quantitatively. Giving numbers is only confusing here. 

DR. FREEMAN: Before we entertain other questions, I would like to have the 

committee’s sense of whether you support what Dr. Hoffmann has just said, 

which seems to be a good summary of what we have said so far? Is there any 

disagreement with what Dr. Hoffmann has just said? 

[NO RESPONSE] 

Then we will take that as a consensus, and we will go on to consider it 

further in the latter part of the day. 

You had another comment, Dr. Petitti? 

DR. PETITTI: Just to emphasize that this information should not be 

quantitatively presented to the consumer because of the potential for 

misinformation. 

DR. FREEMAN: My understanding relative to Question 2 is that there are 

certain elements that are proven to be harmful to human beings that are 

within tobacco that should be listed, though this panel is not recommending 

which specific compounds; that they should not be listed according to 

quantity; and that they should not undergo the same testing that we are 

recommending for tar, nicotine, and CO. I will take that as a consensus at 

this point. 

If that is sufficient for that question, I would like to go on now to the 

third question that we have been asked to consider. 

Question 3. Does the FTC protocol provide information useful to consumers 

in making decisions about their health? 

Yes, Dr. Petitti? 

DR. PETITTI: I think that in the context of the purpose of the FTC protocol, 

which is to provide information that allows consumers to choose cigarettes 

that reduce their risk of disease, the current FTC protocol is misleading in at 

least two important ways. First, it presents the consumer with a single 

number, thus implying that the consumer will receive exactly that exposure. 

Second, I think that the numbers when presented as numbers implicitly 

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suggest that there is a ratio-scaled relationship between machine-measured 

yield and disease risk. I think that these numbers could be made more useful 

by remedying these misleading aspects of the current FTC protocol in ways 

that we have been discussing throughout the morning, 

DR. FREEMAN: Specifically what do you recommend? 

DR. PETIITI: First, present a range of numbers, thereby correcting the 

problem of a single number implying that the consumer will receive 

exactly that amount of exposure; and, second, provide some kind of graphic 

presentation of this information to the consumer in a way that takes away 

the numerical aspect of “9 is 9 times higher than 1and 20 is 20 times higher 

than 1.” 

DR. FREEMAN: Dr. Rickert and then Dr. Hughes. 

DR. RICKERT: I agree. I think the issue is, can the FTC protocol provide 

useful information rather than does it? In other words, are there ways that 

we can take this kind of information and convey it? One of the options 

that has been discussed and also appears in the literature is this idea of using 

the color of tar to communicate the range of variation that one can get in 

tar yields and, also, to allow individual smokers to gauge what they are 

receiving from the cigarette. I think a lot of us feel that if it were possible 

for low-yield smokers, that is those who are smoking the less-than-5-mg 

cigarettes, to achieve a low-yield smoke from that cigarette, there may be 

an accompanying health benefit to that achievement. At the present time, 

however, there is no means for the smoker to ascertain what the yield is. 

If there were some sort of graphic technique for them to visualize this 

process, then that may confer a health advantage to them. 

DR. FREEMAN: Dr. Hughes? 

DR. HUGHES: I have a question for Mr. Peeler. I was struck by the remark 

that talking about health benefits implies a health claim, which I understand 

the tobacco industry has not made with this product. Therefore my question 

to you is, can the FTC require such health education to come from the 

tobacco manufacturers when they have not made that health claim? 

MR. PEELER: The numbers clearly communicate some health benefit to 

some portion of consumers. If we were able to determine that a significant 

number of consumers were being misled by that, we could require some 

corrective information or provide some corrective information. I think the 

concern has always been the one that we started out with in 1960, that as 

a result of that position, there basically were not any tar and nicotine 

numbers being made available to consumers. 

In terms of our present status right now, our jurisdiction is simply to 

require that claims made in advertising be substantiated. Currently, there 

is not an FTC rule, an FTC case, or any legislation requiring the disclosure 

of tar and nicotine data either on labels or in advertising. 

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DR. HUGHES: If some surveys or several surveys showed that most 

consumers inferred a claim of health benefits from these cigarettes, would 

that be important information for the FTC to know when considering 

whether to force the tobacco companies to put in health information? 

MR. PEELER Consumer survey information is absolutely vital to everything 

the FTC does in the regulation of advertising and labeling. Therefore, the 

answer to the first question is yes. The next question is this point that we 

raised earlier: whether there would be the ability to compel disclosure of 

tar and nicotine information absent a health claim. You do get back to the 

tension between having no information out there at all and having just the 

accurate tar and nicotine. 

DR. HUGHES: I think you are misunderstanding, because I am not talking 

about whether they report the numbers or not. Suppose there was a proposal 

that the FTC would require all cigarette advertisements that state anything 

about tar to have a statement that reads something like, “Switching to a lowtar cigarette is a very small health improvement compared to stopping 

smoking.” 

MR. PEELER: There is a legal analysis under the Commission’s unfairness 

authority that could be used to require disclosure of that information, 

assuming the correct factual predicate could be established. 

DR. HATSUKAMI: Regarding health benefits, it seems that based on 

Dr. Cohen’s presentation there are significant numbers of people who 

believe that there are benefits to switching to a lower tar and nicotine 

cigarette, and yet some of the data do not show this relationship between 

tar yield and health benefits, with the exception possibly of lung cancer. 

Therefore, I agree with Dr. Hughes in requiring some kind of label on the 

package explaining that switching to a low-tar and -nicotine cigarette 

may or may not provide health benefits, thereby hopefully correcting 

an apparent misconception. 

DR. FREEMAN: Dr. Benowitz? 

DR. BENOWITZ: I would just like to emphasize that such language has to 

be stated very carefully; I believe for an individual there is very little benefit 

to switching. For the society of all smokers there may be benefit, and I 

would not want to lose that benefit. We have to walk that line of warning 

individuals that this is not going to help you very much, but still encourage 

the whole society of smokers to reduce their tar and nicotine intake. We 

need to find language that will serve both purposes. 

DR. FREEMAN: Dr. Kozlowski? 

DR. KOZLOWSKI: I would like to encourage the panel to note in the report 

that there is a fundamental deficiency in that the current procedures are 

linked to cigarette advertising. A number of presenters mentioned that 

currently one-third of cigarette brands are generics. There is no requirement 

that a cigarette brand be advertised. There is no law that says that you must 

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advertise a cigarette, and, if it is not advertised, there is no option for any 

kind of brand-yield information or any kind of FTC method. I think one 

might see the linking of consumer information solely to advertising as a 

loophole in the system. I would encourage the panel to ask the FTC to try to 

provide some estimate of what percentage of brands are not advertised at all. 

DR. FREEMAN: Mr. Peeler, can you address that question? 

MR. PEELER: As I said earlier, we do not have that information today. 

We could certainly get that for the panel, if the panel would like it. 

DR. FREEMAN: Are there a significant number of brands that are out in the 

market but are not being advertised? 

MR. PEELER: There has been a very large increase in the number of brands 

that we have been reporting because of the increased number of generic 

brands, which are frequently not advertised. 

DR. FREEMAN: And is it true that the FTC does not require that those brands 

undergo the same analysis? 

MR. PEELER: Again, we have to go back to the beginning. The disclosure of 

tar and nicotine is provided for under the FTC’s general authority to regulate 

advertising and to require substantiation of claims in advertising. At one 

point there was an FTC proposal to require the disclosure of tar and nicotine 

content in all cigarette advertising. Cigarette labeling is largely regulated 

by separate Federal statute called the Federal Cigarette Labeling Act. The 

rulemaking was suspended when the cigarette industry voluntarily agreed to 

put this information in all their cigarette advertising. So that is the current 

status of disclosure. Many companies do put that information on their 

packs, particularly with respect to their lower yield cigarettes. I do not 

have an estimate of how many packs that is. 

DR. FREEMAN: Then it is conceivable that there could be cigarettes sold that 

do not have this labeling? 

MR. PEELER: I believe it is likely that there are many cigarettes, particularly 

generics, that do not have these labels. 

DR. FREEMAN: I think that is a very significant point. If the FTC does not 

regulate that, who does? 

MR. PEELER: The content of the cigarette label is largely regulated by the 

Federal Cigarette Labeling Act, which is a Federal statute that requires a 

certain number of disclosures, for example, the Surgeon General’s disclosure, 

and then basically says that, for other statements relating to smoking and 

health, only Congress can impose those additional statements. 

DR. FREEMAN: Thank you. Dr. Hughes? 

DR. HUGHES: I think we have a model with the recent food pyramid. That 

labeling change was accompanied by a massive educational campaign, and 

I do not know who did that, but it seems to me that we need a similar effort 

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Smoking and Tobacco Control Monograph No. 7 

with tar and nicotine. I want my patients to know about nicotine yield 

much more than I want them to know about riboflavin and cholesterol and 

that sort of thing. My question is, why have we not had the same public 

education campaign around nicotine yield, spending at least as much 

money as we did on the food pyramid? 

DR. KOZLOWSKI: To respond to that, there is a question of in whose 

jurisdiction does that campaign fall. I think it is not within the FTC brief 

in any explicit sense to do an extensive education campaign on it, and you 

have just heard that cigarette labeling falls under quite a different procedure. 

DR. FREEMAN: Dr. Townsend? 

DR. TOWNSEND: In response to Dr. Kozlowski’s concern and your obvious 

concern about generics or unadvertised cigarettes being out there in the 

marketplace without any information, that really is not true. While the 

specific numbers are not advertised, the generic products are broken into 

categories of tar deliveries, the same as other brands. For example, you can 

find a generic sold as regular, lights or ultralights. There is information out 

there, even if there is no advertising that carries with it specific absolute 

FTC tar numbers. 

DR. FREEMAN: Would you clarify this point because I am a little confused. 

What would be the difference on the labeling of the generic product vs. the 

one that is advertised? 

DR. TOWNSEND: Let me take one example with the generic cigarette brand 

Doral. The packages are in different colors, the same as other brands, with 

dark green for the regular, light green for the lights, and a real light green 

or a white for the ultralights; and their tar category is stated on the package. 

That is a comparative measure of the FTC tar yield for those cigarettes even 

though there is no advertising that carries the FTC number with it. 

DR. FREEMAN: That is how they are similar. How do they differ? 

DR. TOWNSEND: What I am saying is that there is a distinction in the 

marketplace by virtue of what is written on the pack, that it is a light or 

an ultralight or a regular. 

DR. FREEMAN: I understand. 

DR. TOWNSEND: And by the color of the pack. 

DR. FREEMAN: But other than that, the numbers are not there? 

DR. TOWNSEND: Because many of these products are not advertised, the 

numbers in some cases are not available to consumers. 

DR. FREEMAN: You have clarified my point. Dr. Benowitz? 

DR. BENOWITZ: One of the central recommendations of this panel should 

be that cigarette labeling include these warnings. The other issue that 

concerns all of us is consumer information, and even though it is not a 

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direct charge, I think we should make a strong recommendation that there be 

labeling about yields and the other issues we have been talking about. 

DR. FREEMAN: Are you speaking also on the generic cigarettes? 

DR. BENOWITZ: Yes, on all cigarettes. 

DR. FREEMAN: That is your recommendation? 

DR. BENOWITZ: Yes, because the FTC can regulate advertising, but what 

we are really talking about is labeling on the cigarette packs. If there is no 

vehicle for doing that now, I think we should recommend there be one. 

DR. FREEMAN: Yes, Dr. Rickert? 

DR. RICKERT: I would certainly support what Dr. Benowitz is saying, 

particularly given the amount of confusion that sometimes arises over the 

use of the terms “light,” “ultralight,” and so on. Unless these terms have 

been defined with some specific tar range associated with them, the use of 

the terms without that tar information is certainly open to the potential for 

misleading consumers. 

DR. FREEMAN: Dr. Woosley? 

DR. WOOSLEY: I agree with both of those statements wholeheartedly, but 

I am concerned by the reality of labeling being proscribed by legislation so 

that it is not to be touched by anyone but Congress. If I am interpreting 

that correctly, that is a terrible situation to be in. Let me just go on to say 

that I believe the use of the terms “light” and “ultralight” in advertising are 

perceived as a claim. I think there needs to be a very strong message from 

this committee that those are perceived claims, and they carry with it the 

impression of improved health, and I think that is a form of advertising. 

DR. FREEMAN: Dr. Townsend, can you give the committee any sense of 

what percentage of cigarettes sold in America are in the generic category as 

opposed to the advertised category? 

DR. TOWNSEND: No, I really cannot. There are some generic products or 

low-cost products that are advertised; most, however, are not. I cannot give 

you an exact percentage right now. 

DR. FREEMAN: Thank you. Dr. Cohen? 

DR. COHEN: Dr. Townsend, are you asserting that for cigarettes the color of 

the package is intended to convey the tar level of the cigarette? 

DR. TOWNSEND: In practice, if you look at products that are in the market 

currently, in addition to having the category defined as regular, lights, or 

ultralights on the pack and in the advertising, in many cases the packs are 

different colors. If you look within one brand family, particular brands 

within that brand family that are in the different tar categories do have 

different pack colors. 

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DR. COHEN: Is there an intention on the part of cigarette manufacturers to 

convey information about tar yields by using color on packages, as well as 

terms such as “light” and other descriptive adjectives? 

DR. TOWNSEND: There is an intention, in my opinion, by the cigarette 

industry in general to convey tar information to the consumer so that they 

can make choices. In some brands the different colors are intended to 

convey the different tar category in which they fall, and that category is 

stated explicitly in the advertising. 

DR. FREEMAN: I have been informed by staff that approximately 40 percent 

of cigarettes sold in America are of the generic category. If that is true, then 

I think this is a major issue to be considered here. 

DR. KOZLOWSKI: It appears that Dr. Townsend is indicating that the 

designations light and ultralight are in a sense being used as surrogates in 

a broad sense for tar and nicotine ratings and that they are carrying tar and 

nicotine rating information. My question is, are there industry standards or 

R.J. Reynolds standards for what numbers are required before a cigarette is 

called light or ultralight or is there variance across the industry and in what 

products get the label “light”? 

DR. TOWNSEND: It is my understanding that the definition, of course, has 

changed a little bit over the years, but today the definition is really quite 

consistent. Cigarettes under 6 mg constitute ultralights, those from 6 to 15 

are lights, and above 15 are regulars. 

DR. FREEMAN: Dr. Henningfield? 

DR. HENNINGFIELD: I have a recommendation and a question for 

Mr. Peeler. The recommendation is that, on discovering that FTC does not 

have the means to put on the labeling this information that we are saying 

is so important, I recommend that the FTC use all means at its disposal 

to get this information and make it readily available to consumers. My 

question for Mr. Peeler is, what kinds of things can you do? For example, 

could you put your tar report information at all points of sale, or do people 

just have to write for the catalog? 

MR. PEELER: Let me clarify about the labeling. The place where we are 

preempted on cigarette labeling and where everyone is preempted on 

cigarette labeling is on statements relating to smoking and health, and there 

is a question about exactly where that is. I would think if there were a 

misrepresentation, for example, on a label of the tar content, and that is 

all that there was, that would be something on which the FTC could take 

action. The question of exactly how much information the FTC can 

affirmatively require to be disclosed absent a representation by the company 

is a whole other issue that we would have to look at in light of the panel’s 

recommendations. For example, in the 1970’s when the FTC required 

that health warnings start appearing in advertising, these requirements 

were based on allegations that the advertising at that point was making 

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representations about the cigarette’s healthfulness. The FTC’s actions 

resulted in settlements between the FTC and a number of companies that 

provided for the health warnings in advertising, which ultimately became 

required by statute in 1984. 

The FTC does not have the FDA-type of regulatory power over the 

cigarette industry. We have the power to prevent deceptive statements, and 

we have the power to require the disclosure of certain types of information 

when a failure to disclose that information would be unfair. 

DR. HENNINGFIELD: Can you only regulate what appears in a magazine ad? 

How do we get it to the consumers who do not read the magazine ads or for 

the cigarettes that are not advertised? 

MR. PEELER If you are talking about information about the relationship of 

cigarettes to health, then the advertising and the labeling right now contain 

warnings, and our authority to require additional warnings or descriptions 

would be triggered by what representations are made. 

DR. HENNINGFIELD: So you could not require that a label like the one 

Dr. Harris showed be put on cigarette packages? 

MR. PEELER: Again, what we are here for is to hear the committee’s 

recommendations and take those back to the five commissioners who 

run the agency. I think what you ought to be doing is making those 

recommendations that you think are right, and then it will be up to the 

five commissioners to sort through them in terms of what is within the 

FTC’s authority and what is not within the FTC’s authority. Clearly the 

focus of our concern and the reason that we are here is there has been a 

lot of concern that the current tar and nicotine labeling system is not 

serving its intended purpose, and because we are putting those numbers 

out every year, that is going to be the first thing that we focus on. 

DR. FREEMAN: Yes, you have a comment? 

MS. WILKENFELD: In the seventies and early eighties when the Commission 

published its number, the Office on Smoking and Health made a large chart 

that was available at point of purchase in pharmacies and other places where 

cigarettes were sold so that there was educational information at the point 

of sale. Whether you call that labeling or the Commission would call it 

advertising, I do not know. But the money ran out and that stopped. 

DR. FREEMAN: I would like to just express a personal concern here. I think 

all of us here should be concerned with the effect of a lethal product on the 

American public with respect to morbidity and mortality. On the other 

hand, this meeting has been called by the FTC along with the Congress. My 

concern is that our human concerns do not become engulfed in bureaucratic 

problems. The 40 percent of people in America who are smoking cigarettes 

that you do not oversee still are smoking cigarettes and still have the same 

lethality for those 40 percent. I hope that although we are governed by the 

bureaucracy in a certain way, and you have limits, and we certainly respect 

229 
Smoking and Tobacco Control Monograph No. 7 

that-we do have a Congress that can rule one way or another. I think we 

should speak to the general problem while we are giving you direction. 

MR. PEELER: I would certainly agree with that. 

DR. FREEMAN: Thank you. Dr. Cohen? 

DR. COHEN: Consumers want information that they can use to make 

meaningful decisions. Assume the consumer wants to make the meaningful 

decision as to whether switching to a particular kind of cigarette, say a 1-to 

5-mg tar cigarette, would lead to a significant reduction in health risks. Can 

this panel, given the state of the art, attempt to provide information that 

would be helpful to the consumer as to the relative risk of smoking different 

kinds of cigarettes? If the answer is no, then it is no, but I think that is more 

important information than the information currently available through tar 

numbers because tar numbers do not tell consumers information that is 

meaningful. 

DR. FREEMAN: Dr. Benowitz? 

DR. BENOWITZ: If you tell people that if they take in less tar, there is a small 

benefit, it is not one that should be denied, but I think it is misleading. I do 

not think we can tell people that you are going to reduce your hazard; you are 

going to live longer if you shift to low-yield Cigarettes. So, we are caught in 

a bind. We want to encourage people to minimize the risk, but we cannot 

really tell them it is going to make a huge difference. 

DR. COHEN: I think frankly that this is a subject that ought to command 

the attention of the panel because consumers, like it or not, are using these 

numbers as if they had absolute significance as numbers. The numbers mean 

almost nothing. The panel has to address the question of is there a way of 

informing consumers as to the relative risk, and perhaps the answer is to let 

us inform them that there is not a lot of gain; doing that, frankly, would be 

very useful and maybe more useful than telling them exactly what the tar 

differences are. 

DR. FREEMAN: Dr. Rickert? 

DR. RICKERT I think the committee has thought about that to a large 

extent, and I think there is a consensus that what is really needed is a rather 

large public health education campaign to try to communicate that very 

information to consumers. 

You are also asking for information about risk, and generally this comes 

from epidemiological studies, which by their very nature are extremely 

long and do not provide information that we can use immediately. The 

information that we have today has been gleaned over a number of years 

with respect to relative risk, and as we have seen, there is not much change. 

Now, if one is going to ask what is the effect with today’s cigarettes, then 

we are talking about a period of time that will be measured in tens of years. 

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Unfortunately, we have to come to grips with the problem today, and we 

cannot wait for tens of years to pass to obtain accurate information about 

today’s cigarettes. 

DR. FREEMAN: Dr. Hughes? 

DR. HUGHES: I would like to respond very concretely to what you said, 

Dr. Cohen, and it is my opinion that if there is not information that you 

suggest about the health benefits of switching, the whole system should be 

junked. My concern is that we are going to say, “Yes, there should be this 

big public health campaign,” and nothing will happen. NCI says, “We don’t 

have money for it.” FTC says, “We don’t have the bureaucracy to do it.” 

The FDA says, “We have other more important things to do,” and this whole 

education campaign does not get done. We come up with a range of values 

that still has numbers on them, and people still think that they are doing 

themselves a big benefit, and I would rather junk the entire system than 

to have that happen. 

The only way around it I can see is that the FTC decides that all 

claims of light and ultralight imply a health claim and therefore require 

a disclaimer. That is the only way out of it I can see, to make sure that 

that happens. 

DR. FREEMAN: What form of disclaimer? 

DR. HUGHES: I do not want to micromanage with the wording. Whether 

we say, “You may get a small benefit” or “You will get very little benefit 

compared to stopping smoking,” is a tough question, and I do not think 

we need to decide on that wording. My point, again, is to reiterate what 

Dr. Cohen said, which is that the system is bankrupt unless there is some 

statement about the magnitude of health benefit that you will receive by 

switching to a low-tar and -nicotine cigarette. 

DR. FREEMAN: Dr. Stitzer? 

DR. STITZER: I want to return to a point I made earlier. It seems to me 

that we would be doing a great service if we could implement a new testing 

technique that involved ranges that could display and convince smokers that 

light cigarettes are the same or can be exactly the same as a regular cigarette. 

I think the data show us that all the cigarettes from .4 mg up can look exactly 

the same. They basically are occupying the same place in space. The range 

of variability is the same, and that there is no health benefit for switching to 

light cigarettes because of this dose variation, but there are also some data 

suggesting that the ultralight cigarettes, those .l mg and below, do produce 

a different level of exposure. 

Now, those cigarettes are not popular. They capture a very, very tiny 

segment of the market, but they may make a difference. We do not have 

the health data, but if there is a dose effect for health, those are the only 

cigarettes that are going to make a difference, and it seems to me that a 

new labeling system could potentially convey that kind of information. 

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Smoking and Tobacco Control Monograph No. 7 

DR. FREEMAN: To play devil’s advocate, there seems to be a point on the 

other side that, if the American public becomes confused about the value of 

low dose vs. high dose, would it defeat the purpose of encouraging people 

to switch, assuming there is a benefit to low-dose cigarettes? I think I am 

hearing those two arguments. Yes, Dr. Giovino? 

DR. GIOVINO: I think part of any disclaimer that would be given if you 

decided to do that would include the statement that I read earlier from 

the Surgeon General’s report that any cigarette smoking is dangerous, that 

quitting is absolutely the best thing a person could do to protect his or her 

health, and that reducing to these brands “may.” And that is exactly what 

the Surgeon General’s report says, “May pose reduced risk, provided that 

no compensation occurs.” I think those two caveats are absolutely essential, 

that quitting is better than switching and that provided no compensation 

there may be reduced risk. 

DR. FREEMAN: Dr. Benowitz? 

DR. BENOWITZ: I think there is a second function that the FTC testing does 

perform, and that is to mold what the tobacco companies provide. I do 

think that there has been a reduction in lung cancer if you compare 1950’s 

cigarettes to modern cigarettes, and I would not want to lose that pressure 

to keep yields as low as possible. I think whatever we do, we do not want 

to lose that by saying that it does not matter at all. The other argument 

is if there is a 10-percent reduction of health hazard-which would be very 

difficult to measure by epidemiological means-if you are applying it to 

about 40 million smokers, that can be substantial. And I would not want 

to lose that for the population either. 

I do not want to be misleading. I certainly appreciate Dr. Hughes’ point 

of view, but I think we somehow should not let things slide the other way. 

DR. FREEMAN: Is there any way that you can bring the two points of view 

together? I think this is a very important point. We need to settle it here. 

DR. STITZER: There is just one other thing. The only way that this 

information can be relevant to the individual consumer is if there is a way 

for that individual to judge where he or she falls along the dose continuum. 

Now, that could be accomplished with a lovely sophisticated method like 

Dr. Rickert has described with the color coding. I do not know whether that 

technology is sufficiently available to incorporate into our recommendations, 

but it could be part of our recommendation that we try to develop a system 

that allows the individual smoker to know where they fall on the exposure 

and dose continuum. 

DR. FREEMAN: Yes, Dr. Hughes? 

DR. HUGHES: I disagree a little bit with you, Dr. Stitzer. Even if people 

could tell exactly where they were on the dose continuum, that does not 

solve the problem of the dose response-health benefits curve being so 

shallow. Also, I want to respond to your comment. I am not saying that 

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there is no benefit, and I do not think we should say that there is no benefit 

because I agree the public health argument is there. But the physician in 

me says, “Always oversell your case,” because people do not change very 

much. Again, I do not care what kind of disclaimer or how it is worded, 

but there has to be, again, something about health benefits to the consumer 

in all of this. 

DR. FREEMAN: Dr. Shiffman? 

DR. SHIFFMAN: I think the two issues we have struggled with most recently 

are related. While the system as now constituted has its focus on advertising 

and on showing a single number for an FTC measure of tar and nicotine 

values, in fact there are implicit claims being made both in advertising 

proper and in brand names, which are a form of advertising that imply 

a health claim. Therefore, it seems to me we ought very strongly to 

recommend both that the use of those terms, like “light” and “ultralight,” 

be regulated and that when they are used, they be accompanied in fair 

balance by a disclosure of the sort that Dr. Hughes has suggested. 

I think there is a middle ground that allows us to proceed based on what 

we know and based, I think, on regulatory authority that already exists. 

DR. FREEMAN: Yes, Dr. Zacny? 

DR. ZACNY: Based on Dr. Rickert’s point about state-of-the-art 

epidemiological studies not being done at this time where you can say with 

any degree of certainty what the relationship is between nicotine dose and 

risk of disease with the brand of cigarettes we are dealing with now-the lowyield cigarettes and the ultralow-yield cigarettes-I disagree slightly with 

Dr. Hughes when he says that the relationship may be very shallow. As 

scientists, in any claims we make we can just say that we do not know at 

this time what the relationship is because it takes 10 or 20 years, but based 

on what we know, it would be best not to block vent holes, to take smaller 

puffs, etc. 

DR. FREEMAN: That would be an educational campaign? 

DR. ZACNY: Yes, Maybe I am wrong, but it seems that there may be a doseresponse relationship between risk of lung cancer and how much smoke 

people take into their system, and they may realize a substantial benefit with 

the ultralow-yield cigarette. I do not think we know with certainty, and in 

the absence of that, I think the formulations that we are putting forth with 

bands and ranges are a good idea. 

DR. FREEMAN: Dr. Kozlowski? 

DR. KOZLOWSKI: I would like to draw an analogy to the FDA nutritional 

labeling. For a lot of the items on those labels, there is not persuasive 

epidemiological research to show the dose-response curves for a lot of the 

things that are listed as of interest. I think we do not want to be held to a 

higher standard. Epidemiology takes time. It has its limitations, and the 

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Smoking and Tobacco Control Monograph No. 7 

basic point is there is a lot of labeling that pertains to risks that are only 

approximately known. 

DR. FREEMAN: Dr. Benowitz? 

DR. BENOWITZ: To follow up on Dr. Zacny’s comments, what we really 

would like to know is not brands vs. risk; we would like to know actual 

exposure level. If we were able to measure cotinine or adducts of different 

compounds or whatever in smokers vs. their yields, then we would have the 

basis for recommending that individuals should reduce their exposure. Since 

there is such an overlap with the yields as marketed now, I do not think we 

are ever going to see a difference by yield-that does not mean that the 

rationale for an individual reducing their intake is not valid, and so at this 

point in time we may have to go forward based on scientific rationale and 

plausibility for reducing exposure to toxic materials. 

DR. FREEMAN: Dr. Hoffmann? 

DR. HOFFMANN: I think there is a misunderstanding. It has been shown 

in dozens of studies that there is a dose response with respect to cancer of 

the lungs and the upper respiratory tract by number of cigarettes smoked 

per day, length of time smoking, and groups of cigarettes. This continues 

for ultralow, low, and average cigarettes. There is a dose response with 

respect to cancer but not with respect to coronary artery disease. Any 

cigarette is harmful. But ultralow cigarettes have a lower risk than 

nonfiltered regular cigarettes when you smoke them for 10or more years. 

We should not say that there is no dose response. 

DR. FREEMAN: Dr. Hoffmann, just to follow up on what you said, as far as 

the science is concerned, you indicated that in there is no apparent dose 

response for coronary heart disease? 

DR. HOFFMANN: We do not know from the literature any benefit with 

respect to coronary heart disease. 

DR. STITZER: Dr. Benowitz can speak to this. Is there a dose effect based 

on light vs. heavy smoking for coronary disease? 

DR. BENOWITZ: No, there is not. I would like to add that I agree with 

Dr. Hoffmann that this dose response would provide a rationale for what 

we are doing here today. There are data in pregnancy showing the dose 

response between cotinine level and the weight reduction of the newborn, 

and therefore that is another rationale for another disease that there is a 

dose-response relationship, and therefore, even though we cannot say that a 

particular brand is going to be less hazardous than some other brand, we can 

say that lowering your exposure in general will be beneficial, and then we 

just have to help people to do that. 

DR. FREEMAN: Didn’t Dr. Samet state yesterday that there is no evidence 

that coronary heart disease is reduced by lowering the nicotine or tar content 

in cigarettes? 

234 
Section II 

DR. BENOWITZ: He said that there was no evidence. 

DR. HOFFMANN: That may be the case, but that we have no evidence. 

DR. FREEMAN: I think we should respect those data because I think more 

than 100,000people die each year from cardiac death due to smoking. I do 

not know the exact numbers, and that is a very significant point to argue 

that even smoking low-nicotine, low-tar cigarettes will not protect you as far 

as we know from dying from coronary heart disease. Is that a fair statement, 

Dr. Hoffmann? 

DR. HOFFMANN: No, 1 think we do not know. 

DR. FREEMAN: Let me narrow down the point. Are you saying that there is 

no distinction between the low-tar and -nicotine smokers and the high with 

respect to death from coronary disease? 

DR. HOFFMANN: There is no evidence. 

DR. FREEMAN: No evidence that there is a difference? 

DR. HOFFMANN: No evidence that I am aware of. We discussed it last 

night, and nobody came up with any, but there may be. I am not aware of it. 

DR. PETITTI: Since we are relying so heavily on the 1981 Surgeon General’s 

report, and very few data have come out since then, I would like to read the 

statement specifically about cardiovascular disease: 

The overall changes in the composition of cigarettes that 

occurred during the last 10 or 15 years have not produced 

a clearly demonstrated effect on cardiovascular disease, and 

some studies suggest that a decreased risk of CHD may not have 

occurred. Evidence on the association between CHD and filter 

cigarettes is somewhat conflicting. One major study showed a 

reduction of 10 to 20 percent of coronary deaths among persons 

smoking lower tar and nicotine cigarettes as compared with 

those smoking higher yield cigarettes. 

That was the CPS-I study, but other surveys have shown a slightly 

increased risk of coronary mortality in people who smoke filter cigarettes 

or those who smoke nonfilter cigarettes. Recent unpublished data from the 

Framingham study that were ultimately published do not show a lower CHD 

risk among smokers of filter cigarettes. It is not that there are no data. The 

data that exist show no association of smoking lower yield cigarettes with 

reduction in coronary heart disease morbidity and mortality. 

DR. FREEMAN: I think that is a very, very important point that ought to be 

factored into this discussion. Dr. Cohen? 

DR. COHEN: I was very pleased, Dr. Hoffmann, to hear you clarify an issue 

for me. I heard you say that we can inform people about lung cancer, at 

least. Now, lung cancer is a major issue for people, and what I am wondering 

is, since people use tar as a surrogate for relative harmfulness, might it make 

235 
Smoking and Tobacco Control Monograph No. 7 

some sense to restrict their usage of tar by maybe getting rid of tar and 

talking about cancer-causing compounds or some other component and let 

these numbers communicate meaningful information about something we 

do know something about, rather than where we do not know anything 

about it that is conclusive? Would it be possible, in other words, to indicate 

people’s relative risk with respect to lung cancer for smoking these different 

yield cigarettes? 

DR. HOFFMANN: As I see it, the public associates tar with cancer. 

DR. COHEN: I think they do it more broadly and associate it with overall 

safety. 

DR. HOFFMANN: They are not well informed. The American Cancer Society 

did a fantastic job, publishing this over and over again, and the public is well 

informed with respect to smoking and lung cancer. There has not been the 

same level of information communicated about coronary risk. 

DR. COHEN: In your view though, is it possible to relate the differences in 

tar yield in cigarettes to a reduction in cancer risk? If the answer is yes, it 

seems to me that one of the things the panel might consider doing is trying 

to convey that or recommending that be conveyed. 

DR. FREEMAN: Dr. Rickert? 

DR. RICKERT I would be somewhat reluctant to do that for several reasons. 

First of all, the information with respect to lung cancer and risk reduction is 

from the 1981 Surgeon General’s report that relates to cigarettes that were 

consumed 10 to 20 years prior to that date. My other concern is in terms of 

“tar is tar is tar,” that is, is the quality of the tar from today’s ultralowiyield 

cigarette the same as the quality or the carcinogenic potential of tar from a 

cigarette from many years ago? I do not think we know that the tar of 

today’s cigarette is the same as the tar of the cigarette many years ago that 

was being related to lung cancer. 

DR. HOFFMANN: With respect to your first point, Dr. Rickert, there was 

an International Agency for Research on Cancer monograph in 1986 that 

presented 15 studies that all show between a 13- and 30-percent reduction. 

There are also reports from the World Health Organization, and there is the 

European study by the National Cancer Institute. It did not end with 1981. 

DR. RICKERT I am not uncomfortable with the idea that there is a risk 

reduction. What I am suggesting is that we really do not have enough 

information about the tar characteristics of today’s cigarettes to directly 

compare them. 

DR. HOFFMANN: You can do only risk biomarkers. Otherwise you cannot 

do it. 

DR. RICKERT: I agree. 

DR. FREEMAN: Yes, Dr. Hoffmann. 

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Section II 

DR. HOFFMANN: I believe that we should do better education. I do not 

think that including whether it is plus or minus 3 mg or 5 mg helps the 

public. The public has to be much better informed. 

DR. FREEMAN: It appears from what I have heard here on the question of 

does the ETC protocol provide information useful to consumers in making 

decisions about their health, that the answer seems to be not sufficiently so, 

and we have had an interesting discussion and debate here this morning 

concerning various aspects of that decision. 

Things that stand out in my mind are what do the numbers mean to 

the public? Dr. Cohen has been eloquent in raising that issue. What is the 

value of projecting a range per type of cigarette to the public? What is the 

value of any kind of color coding to the public? What would be the value 

of presenting a graph to the public so a person could see by graph form what 

the differences in cigarettes are? We also have heard this morning, unknown 

to me before, that approximately 40 percent of cigarettes are not looked at 

by the Federal Trade Commission because they are not advertised. 

MR. PEELER: They are looked at, and they are tested. The results are 

reported, but unless the manufacturer either voluntarily puts that 

information on the label or unless they advertise, those numbers aren’t 

necessarily communicated directly to consumers. 

DR. FREEMAN: Thank you for that correction. The bottom line is the public 

does not know those numbers. 

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BLANK PAGE 
Section III 

Recommendations and Findings 

DR. FREEMAN: Good afternoon, I am Dr. Harold Freeman. I am the 

chairman of the President’s Cancer Panel. At the request of the Congress 

and the Federal Trade Commission, an ad hoc committee of the President’s 

Cancer Panel has met over the last 2 days to consider the Federal Trade 

Commission test method for determining tar, nicotine, and carbon 

monoxide levels in cigarettes. Before I get into our statement, I would like 

to put the problem of tobacco into perspective. Tobacco use is the number 

one cause of preventable death in America. Cigarette smoking is responsible 

for more than 400,000 premature deaths every year in this country and 

causes one-third of cancer deaths and one-third of heart disease deaths. 

Although smoking is declining among adults in the United States, it is 

discouraging that smoking is not declining among children, and in fact, 

smoking prevalence among adolescents has changed little for more than 

a decade. 

I have with me Dr. Saul Shiffman of the Department of Psychology, 

University of Pittsburgh; Dr. Diana Petitti, director of the Division of 

Research and Evaluation, Kaiser Permanente; and Dr. William Rickert of 

Labstat, Inc. 

This committee reviewed articles, studies, and other documents and 

heard presentations from a variety of experts, including tobacco industry 

scientists, on the subject of the ETC test method for determining tar, 

nicotine, and carbon monoxide levels in U.S. cigarettes. We have deliberated 

with the goals of answering questions and making recommendations. Our , 

deliberations centered around the following three summary questions: 

1. Does the evidence presented clearly demonstrate that 

changes are needed in the current Fz% protocol for 

measuring tar, nicotine, and carbon monoxide? If yes, 

what changes are required? 

2. Should constituents other than tar, nicotine, and carbon 

monoxide be added to the protocol? 

3. Does the FX protocol provide information useful to 

smokers in making decisions about their health? 

I. The committee reached the following conclusions with respect to the 

first question. 

A. The smoking of cigarettes with lower rnachine-measuredyields has 

a small effect in reducing the risk of cancer caused by smoking, no 

effect on the risk of cardiovascular diseases, and an uncertain effect 

on the risk of pulmonary disease. A reduction in machinemeasured 

239 
Smoking and Tobacco Control Monograph No. 7 

tar yield from 15 mg tar to 1mg tar does not reduce relative risk from 

15 to 1. 

B. The FKtest protocol was based on cursory observations of human 

smoking behavior. Actual human smoking behavior is characterized 

by wide variations in smoking patterns, which result in wide 

variations in tar and nicotine exposure. Smokers who switch to lower 

tar and nicotine cigarettes frequently change their smoking behavior, 

which may negate potential health benefits. 

C. Accordingly, the committee recommends the following changes to 

the FTC protocol: 

1. This system should also measure and publish information on 

the range of tar, nicotine, and carbon monoxide yields that most 

smokers should expect from each cigarette sold in the United 

States. 

2. This information should be clearly communicated to smokers. 

3. A simple graphic representation should be provided with 

each pack of cigarettes sold in the United States and in all 

advertisements. The representation should not imply a one-toone relationship between measurements and disease risk. 

4. The system must be accompanied by public education to make 

smokers aware that individual exposure depends on how the 

cigarette is smoked and that the benefits of switching to lower 

yield cigarettes are small compared with quitting. 

D. There should be Federal oversight of cigarette testing, but such testing 

should continue to be performed by the tobacco industry and at 

industry expense. 

E. The questions involved in the purpose, methodology, and utility 

of the FTC protocol are complex medical and scientific issues that 

require the ongoing involvement of Federal health agencies, 

including the National Institutes of Health, Food and Drug 

Administration, and Centers for Disease Control and Prevention. 

F. The system should be reexamined at least every 5 years to evaluate 

whether the protocol is maintaining its utility to the smoker. 

G. When a cigarette manufacturer makes significant changes in cigarette 

design that affect yields, it should notify the appropriate Federal 

agency. 

11. With regard to the second question, the committee recommends that 

to avoid confusing smokers, no smoke constituents other than tar, 

nicotine, and carbon monoxide be measured and published at the 

present time. Smokers should be informed of the presence of other 

hazardous smoke constituents with each package and with all 

240 
Section III 

advertisements. These constituents should be classified by toxic 

effects. 

111. In considering the third question, the committee reached the following 

conclusions: 

A. Information from the testing system is useless to smokers unless 

they have ready access to it. The information from the testing system 

should be made available to all smokers, including those who smoke 

generic brands and other brands not widely advertised. 

B. Brand names and brand classifications such as “light” and 

“ultralight” represent health claims and should be regulated and 

accompanied, in fair balance, with an appropriate disclaimer. 

C. The available data suggest that smokers misunderstand the FTC test 

data. This underscores the need for an extensive public education 

effort. 

I would like to underscore twomajor points: First, the health benefits 

of switching to low-tar and -nicotine cigarettes are minimal compared to 

quitting entirely, and finally, in effect, how you smoke is much more 

important than what you smoke. 

We have deliberated for 2 days. We believe these findings are very 

important to the health of the American public. We are dealing with a 

product that is lethal, that needs to be controlled, and we believe that -. 

these recommendations will lead to some control. I would open it up 

for questions to my colleagues or to myself. 

PARTICIPANT: Dr. Freeman, what do you expect to be the next step in the 

educational process for consumers? 

DR. FREEMAN: The findings from the deliberations of this committee will 

be reported to the Director of the National Cancer Institute, who will then 

formulate a report that will be passed on with the help of the President’s 

Cancer Panel to the appropriate agencies and the Congress. 

PARTICIPANT: That is a lot of reporting. Can you predict what might 

happen next? 

DR. FREEMAN: I do not think we can predict what is going to happen in the 

future, but our hope is that since the FTC methodology has been in effect 

from 1967 and was based on findings that relate to 1936, and since in the 

last 25 years there has been a considerable change in our knowledge through 

research, as well as in the type of cigarettes that are being smoked, we now 

believe that these changes are very essential and should be put into effect 

very soon. 

No one can predict because we are dealing with the FTC, possibly 

other agencies of the Government, and the Congress, and no one on this 

committee can predict how rapidly these changes may take place, but we 

believe they are very important. 

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Smoking and Tobacco Control Monograph No. 7 

PARTICIPANT: Are you saying that you are recommending keeping the 

current FTC testing method and expanding it in some way or are you talking 

about a whole new testing system? 

DR. FREEMAN: Let me reemphasize that we are recommending the keeping 

of the basic parts of the FTC testing methodology with the exception that 

we want to expand testing to show the ranges of possible effects of the three 

substances that are being measured. The reason that we believe this is 

important is that the research has shown that people who smoke cigarettes 

that, for example, are labeled as having low tar can get a much higher dose 

from that cigarette than the label may indicate. For example, if you have a 

low-yield cigarette, the way you smoke it, the rapidity of the puffing, the 

depth of the puffing, whether you block the ventilation holes, etc., can have 

an extraordinary effect on the real dose to the patient. Disease, we believe, 

is related to the dose of carcinogens and other toxins. 

PARTICIPANT: The impetus for this effort came from Congressman 

Waxman, a Democrat in the Congress. Now the Congress is primarily 

Republican. What effect do you think this is going to have on your 

recommendations? 

DR. FREEMAN: It is conceivable that people in power who have 

philosophies that are different from Congressman Waxman’s could present 

barriers to our recommendations. We are hopeful though that even with 

these changes that the logic of what we are saying will make sense even to 

people who may disagree with what we are recommending in principle. 

There are people, for example, who may wish to diminish the fight against 

tobacco, and I am sure you are referring to them. I am hopeful that even 

such people will listen to the logic of reporting to the American public the 

truth of a finding that is responsible for 400,000 deaths a year and give the 

public the chance of making an intelligent decision. We are not saying, 

“Eliminate cigarettes.” We are not saying, “Stop using the methodology that 

has been present for 25 years.” We are saying, “Give an honest report to the 

American public and show them the range of the risk that they are subjected 

to.” I hope that everybody, Democrat, Republican, conservative, or liberal, 

will follow that logic. 

PARTICIPANT: You are suggesting, in addition, putting the CO on cigarettes 

and also putting other ingredients? 

DR. FREEMAN: One of the recommendations that I read to you indicates 

that we believe that in addition to putting the ranges of the tar, nicotine, 

and carbon monoxide that are now being measured with one number, we 

want to change that to a range because that is a more truthful statement. 

This committee is also recommending that certain key harmful substances 

known to be in cigarettes (we are not saying which ones should be listed) 

should be given as information to everyone who buys a package of cigarettes. 

We believe that if this is done in food, which does not apparently have the 

toxic effect of tobacco, then we believe it should be done in this lethal 

product. 

242 
Section 111 

PARTICIPANT: Could you explain the graphics that you would put on the 

package? 

DR. FREEMAN: I am going to refer this question to Dr. Rickert. 

DR. RICKERT There are a number of different ways of looking at that 

particular problem. The graphics could involve a number of different issues; 

for example, it could involve a color representation of the cigarette filter. 

It could represent some icon that illustrates putting all of this information 

together. A number of different possibilities were discussed, and I do not 

think that the committee recommended any specific procedure. I think 

the feeling was that there should be some way of communicating the 

information to smokers without total reliance on numbers themselves. 

PARTICIPANT: What would be the purpose? I do not understand the 

purpose of the graphics overall. 

DR. RICKERT The graphics would make several points. First of all, the 

point that yields to smokers depend on how the cigarette is used; that is, 

if you have a graphic, it gets away from the idea that there is a fixed amount 

of whatever the constituent happens to be. The purpose of the graphic is 

to illustrate the variable nature of the smoking characteristics. 

DR. SHIFFMAN: If I may add, we thought it was very important to 

communicate to American smokers that what you get depends on how 

you smoke and that any system that simply gives one number is, therefore, 

inherently misleading. So, we envisioned a graph that would show you 

a band within which your particular exposure might lie and that will 

give smokers information on which they can make more accurate, more 

reasonable comparisons among brands. We think they will find that there 

is a good deal of overlap among brands that they now consider to be 

different. 

PARTICIPANT: You said “light” and “ultralight.” Some people say that 

those words represent health claims. Could you explain a little bit more 

about that? How does that represent a health claim, and what kind of 

disclaimer would be used? 

DR. FREEMAN: It is the committee’s belief that the public infers health 

claim meanings from these labels, whether they be light, ultralight or 

whether they be the numbers in tar and nicotine. It is anecdotal, and also 

studied, that people look at these numbers and these claims and translate 

them into what it means for their own destiny. The information gathered at 

this meeting indicates that smokers should not be making these predictions, 

first of all, and second, if the labeling by the cigarette industry of ultralight 

implies that you are better off according to health, if that is so, and we 

believe that this is so, then that represents a health claim on the part of the 

advertiser. If it is a health claim, it should be followed by a disclaimer saying 

that it is not a health claim, if it is inferred to be a health claim. 

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Smoking and Tobacco Control Monograph No. 7 

DR. SHIFFMAN: I think, again, specifically we want to be sure that the 

smoker understands that smoking a cigarette that is labeled as light or 

ultralight does not necessarily protect them from the health risks of smoking 

and that, in that sense, cutting down in this way may not keep people from 

being cut down eventually by their smoking habit. We do think that the 

public perceives those labels as implicit health claims. 

DR. FREEMAN: It is even conceivable that a low-tar cigarette smoked in a 

certain way may have the same health risk as a’regular cigarette, and we have 

pointed out in what I have already said that there is no scientific evidence 

that any level of tar in cigarettes protects one against death due to coronary 

heart disease. 

PARTICIPANT: The other substances that you referred to, are you going to 

talk about numbers? 

DR. RICKERT: I think that what the committee felt in that area was that at 

the present time, since there is evidence that consumers tend to misinterpret 

the existing numbers, that to add additional numbers may add to that 

confusion. At the same time there was the concern that there are additional 

agents, other than tar, nicotine, and carbon monoxide, that have definite 

implications for health. It was anticipated that these compounds would be 

classified in various ways, for example, “carcinogens,” and then there may 

be a list of several carcinogens. There would be a list based on toxicological 

effects but not including any numerical measurement. 

PARTICIPANT: Can the machinery that is currently used to test cigarettes be 

used? 

DR. FREEMAN: We were told by an expert today that there may be some 

fine tuning that will be necessary to use the current equipment to do this 

kind of testing. 

PARTICIPANT Who would determine what that range was and how many 

times the machine smoked or how long the puffs? 

DR. FREEMAN: This committee did not go into that kind of detail. We are 

talking about the principle, and the principle is that we know that human 

smokers smoke in different patterns. Some smokers puff many times in a 

minute, and some smokers may puff once a minute. Some smokers puff 

deeply, and there are other factors that I could mention. While we are not 

trying to micromanage how this should be done, the principle is that we 

would like the machine measurement to more closely mimic the variation 

that humans evidence in their patterns of smoking to give a more honest 

range of what a given milligram of tar really represents in range. We do not 

believe it is accurate at all; in fact, it is misleading to give one number when 

the pattern of smoking can change that number radically with respect to 

dose. 

DR. SHIFFMAN: What the panel intended was that the range represent the 

range of human smoking of particular brands so that the machine would 

244 
Section 111 

model that under different parameters, which might include things that are 

now not dealt with in the lTC protocol, such as the blocking of ventilation 

holes that are used to dilute the smoke in some brands that now list as being 

low yield, but in fact can become high yield when a human finger or a 

human lip blocks those vents. 

PARTICIPANT Can you tell us what the role of other Federal agencies is 

going to be? 

DR. FREEMAN: I am not an expert on the bureaucracy of America. However, 

we did get somewhat of a description of the FTC role in our meeting here 

today, which is a role that I understand deals with truth in advertising as 

one of its major roles. And to make a personal statement here, I think that 

is a limited role with respect to what we are trying to accomplish for the 

American public. 

We found out today that 40 percent of cigarettes smoked in America are 

generics, and these for the most part are not advertised. However, the FTC 

in most of its role is limited to making statements about cigarettes that are 

advertised. So that if nearly half the cigarettes smoked in America are not 

advertised, it diminishes the FTC’s role. Yet, the American public needs to 

know about the lethal nature of all cigarettes. 

Now, as far as the FDA is concerned, again, I am not an expert on what 

they do, but I think their role is different from the FTC and may get more 

into the range of health concerns, hopefully. So, I cannot give you a finite 

answer. Perhaps my colleagues can help me out. 

DR. SHIFFMAN: I would just add that the current FTC system operates 

under a voluntary agreement with the tobacco industry and cigarette 

manufacturers, and the representatives of that industry who addressed us 

during this meeting expressed an interest on the part of the industry of 

keeping consumers and smokers informed. We expect that they would 

follow through on that then in taking this step to make sure that accurate, 

useful information is available to smokers. 

PARTICIPANT: Is it your understanding that if the regulatory agencies 

wanted to do this, that legislation would be necessary? 

DR. FREEMAN: To do exactly what? 

PARTICIPANT: To carry out your recommendations? 

DR. FREEMAN: It is our belief that most of what we have recommended 

could be carried out by the FTC without congressional change. Our worry 

is that 40 percent of cigarettes are not regulated in a similar manner. Our 

concern is about the health of the American public and that the bureaucracy 

that we must go through to accomplish some of these things sometimes 

is a barrier to that. The FTC has regulations; the FDA has regulations, but 

sometimes what must be done or what should be done to save lives is 

beyond the confines of a certain agency, and this is somewhat of a problem. 

245 
smoking and Tobacco Control Monograph No. 7 

PARTICIPANT: You said that this information would be useless unless 

smokers had ready access to information, including smokers of generic 

brands. In view of what you said about the FTC’s jurisdiction, how do 

you anticipate getting that? 

DR. FREEMAN: This came up very honestly today. We have not had 

time to think in depth about it. This was probably a surprise, even to this 

committee, that that problem is so large, that 40 percent of cigarettes are of 

the generic type, and honestly I do not have a good answer to that question. 

It may be that the FDA and other agencies could help in some respects, but 

I will refer this question to my colleagues to see if there is an answer to that. 

DR. PETITTI: I could only repeat, I think, what we heard this morning, 

which is that some of these changes might, in fact, require congressional 

action, particularly if they resulted in changes in the labeling law. We are 

saying that there may be the need to put things on cigarette packs in order 

to adequately inform the American public about the FTC protocol. 

PARTICIPANT: Looking ahead to the next 5-year review, do you see any gaps 

in research areas that need to be addressed? 

DR. FREEMAN: Yes, we do. First of all, we have this paper. Where we are 

now with respect to our current knowledge, of course, is based on research, 

not perfect research, but we know a lot more now than we knew in 1950, 

when Ernst Wynder and others showed that tobacco is associated with 

death. So, research is a critical element and at any time I think we must act 

on what we know, but we must always move forward to finer knowledge. 

For example, further research is needed to determine the extent to which 

smokers of lower tar and nicotine cigarettes are less likely to attempt to quit 

smoking. There is some preliminary evidence, for example, that low-tar 

smokers may have less tendency to quit smoking. This would be very bad 

if it turns out to be true. It needs further research. 

Next, to adequately understand and evaluate the impact of what 

is called compensation, research is required to assess the extent to which 

other biomarkers are correlated with machine-measured yields of the same 

substance. By compensation we refer to the point that low-tar smokers 

frequently smoke more cigarettes apparently to get the physiological dose 

of nicotine, which of course is an addictive substance. Compensation needs 

to be studied further to see what effect it may have, and certain biomarkers 

may come in handy to help us. Third, the differences in smoking patterns 

in different ethnic groups should be studied for the implications for health 

education and consumer information. We know, for example, that AfricanAmericans tend to smoke cigarettes that are higher in tar and tend to smoke 

mentholated cigarettes. Other examples could be given. Poor Americans 

tend to smoke higher tar cigarettes. Educated Americans tend to smoke 

lower tar cigarettes. These are all very important questions that we only 

have preliminary information on, and these’things need to be studied much 

more deeply. Finaly, a system should be developed to help smokers gauge 

246 
Section III 

where their individual smoking behavior places them on a dose continuum. 

What diseases you develop, whether it be cancer or anything else, is often 

associated with the dose that you receive, and individuals need to know 

what dose they are receiving. There may be other research questions, and 

1 will open it up for Dr. Rickert and Dr. Shiffman to comment. 

DR. SHIFFMAN: I would add only that in addition to refining our knowledge 

in these areas that there may be some very different products for smokers on 

the horizon. We heard some indication of those in the press, and the system 

would have to be very carefully considered in order to properly evaluate new 

kinds of products aimed at smokers. 

DR. FREEMAN: I think using research in a different way, we need to better 

understand the way the people in power deal with tobacco in America. It is 

a substance that is high in the economy. 

If cigarettes were invented today, they probably would be outlawed since 

they kill 400,000 people a year. However, it is deeply integrated into our 

economy. It affects policymaking. Sometimes there is a conflict, in my 

opinion, between making regulations and trying to balance the budget. 

America in one of its Government roles is saying that tobacco kills 

400,000 American people. Other parts of Government are selling it overseas 

and growing it in America. These are deep problems. They require further 

research and knowledge and action. 

Are there other questions? 

If not, I would like to conclude by expressing my privilege of chairing 

this committee. We brought together the best experts in America on the 

subject. Dr. Dietrich Hoffmann, for example, is one of the pioneers in the 

study of tobacco, and there were others, and it is a privilege to chair this 

committee. It is our hope that these deliberations will have an effect on the 

American public with respect to saving lives and preventing disease. 

Thank you very much. 

24 7 
BLANK PAGE 
Section IV 

Overview of 1980to 1994Research 

Related to the Standard Federal Trade 

Commission Test Method for Cigarettes 

Michael D. Mueller 

INTRODUCTION This chapter provides an overview of the major studies related 

to the Federal Trade Commission (FTC) test method for determining tar, 

nicotine, and carbon monoxide (CO) yields of cigarettes compared with 

yields experienced by smokers, with special reference to low-tar and lownicotine cigarettes. Most of the studies reviewed here were published since 

1980; studies published prior to 1980 were extensively reviewed in the 1981 

Surgeon General’s report (U.S. Department of Health and Human Services, 

1981). 

The apparent differences between stated yields, as measured by the 

FTC test method, found in cigarette advertising and on some cigarette packs 

and actual amounts received by smokers appear to be largely attributable to 

compensation behaviors related to nicotine and possibly other substances 

in cigarette smoke. For example, when smokers switch to low-tar and lownicotine cigarettes, they tend to increase the volume of inhaled smoke per 

cigarette or increase the number of cigarettes smoked so as to maintain a 

steady-state level of nicotine in their blood. They may also increase the 

volume by changing their puffing behavior and increase yield by blocking 

ventilation holes in filters. 

Changes in puffing patterns can substantially alter tar and nicotine 

yields, as reported by Rickert and colleagues (1983), who investigated the 

impact of varying levels of butt length, puff duration, puff interval, puff 

volume, and blocking of ventilation holes. 

The differences in advertised tar and nicotine yields of cigarettes 

compared with the amounts received by smokers result largely from 

differences between the smoking parameters of the FTC test method and 

actual smoking behaviors. These differences can substantially alter the 

amounts of tobacco smoke constituents that smokers inhale. The FTC 

method was devised in 1967, and it is not clear whether these parameters 

were based on actual human smoking patterns and behavior. Furthermore, 

cigarettes have undergone substantial changes in design and content over 

the past 40 years. Also, much more is currently known about smoking 

behavior; pharmacodynamics and pharmacokinetics; and the measurement 

of tar, nicotine, CO, and other substances in cigarette smoke as well as in 

blood, plasma, urine, and expired air in smokers. 

249 
Smoking and Tobacco Control Monograph No. 7 

Rickert and Robinson (1981, p. 401) emphasize that 

even if compensation [changes in smoking patterns to increase 

smoke intake per cigarette] did not occur, it is likely that 

smoking machine parameters fixed about 20 [years] ago no 

longer represent the average smoker, who probably takes 

puffs of more than 45 mL every 40 s instead of a 35-mL 

puff every 58 s. 

There are harmful substances in tobacco and tobacco smoke other than 

tar, nicotine, and CO. These include hydrogen cyanide (HCN), acrolein, total 

aldehyde, and tobacco-specific nitrosamines (TSNAs). Levels of some of these 

harmful substances in low-tar and low-nicotine cigarettes probably differ 

among brands and may also differ within brands when cigarettes are smoked 

differently. 

Smoking patterns may be influenced by factors other than nicotine 

dependence. Pomerleau and Pomerleau (1984) pointed out that there is 

substantial evidence that many cigarettes are smoked for reasons other than 

to receive nicotine. They cite research indicating that smoking patterns are 

influenced in part by environmental situations, emotions, personality, and 

motivation. 

Robinson and coworkers (1983) found that smoking compensation 

behaviors may lead to disproportionate increases in CO and HCN when 

smokers switch to low-nicotine cigarettes. 

Thus, research over the past 15 years has created multiple arenas within 

which scientists and policymakers may reexamine the accuracy and relevance 

of the FTC testing method and, if necessary, redesign it. 

PARAMETERS OF The current FTC test method is based on four parameters: 

THE FI'C TEST puff frequency (every 60 seconds), puff volume (35 mL), 

METHOD AND puff duration (2 seconds), and a butt length that varies with 

CURRENT SMOKING cigarette type. Darrall (1988) noted that these parameters 

PATTERNS were set as long ago as 1936 and were not based on observed 

smoking patterns. For individual smokers, puff volume has been reported to 

range from 23 mL to 60 mL; puff duration is known to vary from 0.8 seconds 

to 3.0 seconds. Typically, butt length is set at 23 mm, or filter and overwrap 

plus 3 mm, whichever is longer; however, the FTC reported that, for 135 of 

176 brands tested, butt length was more than 30 mm (Kozlowski, 1981). 

Cigarette design has undergone significant change over the past several 

decades. Cigarette manufacturers can influence yields of tar, nicotine, and 

other substances through changes in wrapping paper porosity; tobacco 

packing density; and filter-related factors such as ventilation, particulate 

matter retention, and pressure drop. Benowitz and colleagues (1983) noted 

that delivery of tobacco substances also may be influenced by how fast the 

paper burns because this may determine how long a cigarette is smoked. 

Study results indicate substantial differences in yields when FTC test method 

parameters are varied (Table 1). 

250 
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251 
Smoking and Tobacco Control Monograph No. 7 

Gori (1990a) noted that machines, unlike humans, smoke each cigarette 

in exactly the same way. Smokers usually inhale after taking a puff, and 

inhalation seems to be largely under the influence of nicotine demand. 

When smoking machines were invented, little was known about inhalation 

patterns. Today, inhalation can be measured with various biological markers, 

such as CO and cotinine (an indicator of nicotine intake). 

In a study of eight smokers, Gust and colleagues (1983) observed that the 

number of puffs and the duration, volume, and time between puffs varied 

with each smoker. All these factors affect the amount of smoke constituents 

to which the smoker is exposed. Gust and colleagues also noted that smoking 

patterns can vary as a smoker smokes a single cigarette. 

Observations of smoking behavior reveal that smoking patterns are 

influenced by a wide range of factors, including degree of nicotine 

dependence, environmental cues, stress levels, and personality variables. 

A survey of 1,200 randomly selected smokers and ex-smokers in the 

United States and Europe showed that consumers believe that the tar yields 

stated on cigarette packages accurately represent what is received by the 

smoker (Gori, 1990b). The majority of respondents indicated a belief 

that the published yield is equal to the amount consumed per cigarette. 

However, tar intake is related to nicotine intake, and individual intake 

of tar varies according to the nicotine levels of cigarettes and the level of 

nicotine dependence of smokers. 

Guyatt and coworkers (1989a, p. 192) studied the changes in puffing 

behavior during the smoking of a cigarette. The researchers reported 

The most important change in puffing behavior during a single 

cigarette is the reduction in puff volume since this directly 

affects smoke uptake. Most subjects showed this effect, but the 

proportional change was independent of the tar level of the 

cigarette smoked or the sex of the subject and was consistent 

between sessions. However, there were significant betweensubject differences indicating that each individual had [an] 

idiosyncratic pattern. Most subjects control puff volume by 

varying the duration, mostly by truncating the latter part of 

the puff. 

IMPACT OF CHANGING Schlotzhauer and Chortyk (1983) examined the 

PARAMETERS OF THE ITC influence of varying smoking machine parameters 

TEST METHOD ON ABSOLUTE on yields of tar, nicotine, and other selected 

YIELDS OF A CIGARETTE smoke constituents from an ultralow-tar cigarette. 

BRAND AND RELATIVE The smoking machine parameters were changed 

YIELDS OF DIFFERENT BRANDS to reflect the deeper inhalation, more frequent 

puffs, and vent blocking evident among smokers of lower yield cigarettes. 

Specifically, volume was varied from the standard 35 mL to 45 mL and 

55 mL; frequency of puffs was doubled; and puff duration was increased 

from 2.0 to 3.0 seconds. Only one parameter was varied at a time; yields 

were measured with vent holes both unblocked and completely blocked. 

252 
Section IV 

As shown in Tables 2 through 4, changing one parameter at a time 

produces substantial increases in yields, and when cigarettes were machine 

smoked at the average of the parameters used in Tables 2 through 4, as 

shown in Table 5, total particulate matter (TPM) yields were approximately 

doubled, and increases of 96 to 271 percent in the individual components 

were observed. 

TAR AND NICOTINE The issue of compensation has become a central concern in 

YIELD BY THE FTC assessing intake of tar, nicotine, CO, and other constituents 

TEST METHOD AND constituents of tobacco smoke, particularly with regard 

AMOUNTS DELIVERED to cigarettes described as low tar and low nicotine. Various 

TO SMOKER researchers have reported no correlation between cigarette 

brand yield and actual exposure and substantially higher relative exposures 

from low-delivery cigarettes than indicated by quantitative differences in 

stated yields (Rickert and Robinson, 1981). 

The current primary measurement of the carcinogenic potential of a 

cigarette is its tar yield. Kozlowski and colleagues (1980a) noted that tar 

yield depends in part on the number of puffs per cigarette and that a major 

factor in tar reduction has been reduced cigarette length, which results in 

fewer puffs per cigarette during standard FTC testing. Increasing the number 

of puffs can lead to substantial increases in tar yields. 

Table 2 

Effect of increased puff volumes on cigarette mainstream smoke under FTC conditions of puff 

frequency (60 seconds) and puff duration (2 seconds) 

Change (2%) Change (&%) 

35-mL 45-mL From FTC 55-mL From FTC 

Results Volume Volume Values Volume Values 

Cigarettes Smoked 20 20 - 20 -

Total Puffs 152 150 -1 150 -1 

PuffslCigarette (average) 7.6 7.5 -1 7.5 -1 

Total Volume Inhaled (mL) 5,320 6,750 +27 8,250 +55 

TPM (mg) 

TPM/Cigarette (mg) 

86 

4.3 

95 

4.7 

+10 

+10 

135 

6.7 

+57 

+56 

TPM/Puff (pg) 566 633 +11 900 +59 

Phenol/Cigarette (pg) 12 17 +41 23 +92 

GlyceroKigarette (pg) 327 624 +91 1,000 +206 

CatechoVCigarette (pg) 28 28 0 43 +54 

HydroquinonelCigarette(pg) 23 27 +17 41 +61 

Nicotine/Cigarette (pg) 378 502 +33 713 +88 

Neophytadiene/Cigarette (pg) 15 32 +113 39 +160 

Palmitic AcidKigarette (pg) 

C,,AciddCigarette (pg) 

35 

33 

63 

61 

+80 

+85 

64 

55 

+83 

+67 

Key: TPM =.tofa/par7jculate matter. 

Source: Schlotzhauer and Chortyk, 1983. 

253 
Smoking and Tobacco Control Monograph No. 7 

Table 3 

Effect of increased puff frequency and increased puff duration on cigarette mainstream 

smoke composition 

60-Second 30-Second Change 3-Second Puff Change 

Results Frequency Frequency (+%) Duration (2%) 

~ ~~~ ~ 

Cigarettes Smoked 20 20 0 20 0 

Total Puffs 152 28 1 +85 150 -5 

Puffs/Cigarette (average) 7.6 14.0 +85 7.5 -5 

Total Volume Inhaled (mL) 5,320 9,835 +85 7,800 +47 

TPM (mg) 86 205 +138 166 +93 

TPM/Cigarette (mg) 4.3 10.2 +138 8.3 +93 

TPM/Puff (pg) 566 728 +29 1,106 +93 

PhenoVCigarette (pg) 12 20 +67 13 +8 

Glycerol/Cigarette (pg) 327 1,542 +371 795 +143 

Catechol/Cigarette (pg) 28 66 +136 70 +150 

Hydroquinone/Cigarette (pg) 23 50 +117 40 +74 

Nicotine/Cigarette (pg) 378 961 +154 61 8 +63 

Neophytadiene/Cigarette (pg) 15 29 +93 53 +253 

Palmitic Acid/Cigarette (pg) 35 41 +17 39 +11 

C,, Acids/Cigarette (Fg) 33 34 +3 30 -10 

Key: TPM = total particulate matter. 

Source: Schlotzhauer and Choiiyk, 1983. 

Table 4 

Effect of obstructing tipping paper ventilations on cigarette mainstream smoke composition 

FTC FTC With Obstructed Change 

Results Conditionsa Perforations (.%) 

Cigarettes Smoked 20 20 0 

Total Puffs 152 131 -14 

Puff s/Ciga rette (average) 7.6 6.5 -14 

Total Volume Inhaled (mL) 5,320 4,584 -14 

TPM (mg) 86 256 +198 

TPMKigarette (mg) 4.3 12.8 +198 

TPM/Puff (pg) 566 1,969 +248 

Phenol/Cigarette (pg) 12 19 +58 

Glycerol/Cigarette (pg) 327 1,001 +206 

CatechoVCigarette (pg) 28 58 +lo7 

Hydroquinone/Cigarette (pg) 23 53 +130 

NicotineKigarette (pg) 378 839 +122 

Neoph ytadiene/Ci garette (pg) 15 50 +233 

Palmitic Acid/Cigarette (pg) 35 85 +143 

C, ,Acids/Cigarette (pg) 33 76 +I 30 

a 35-mL puff volume, 60-second puff frequency, 2-second puff duration. 

Key: TPM = total particulate matter. 

Source: Schlotzhauer and Chotiyk, 1983. 

254 
Section IV 

Table 5 

Effect of combined compensatory parameters on yields of mainstream smoke components 

Frc New Change 

Results Conditions Conditionsa (a%) 

Cigarettes Smoked 20 20 0 

Total Puffs 152 236 +55 

PuffdCigarette (average) 7.6 11.8 +55 

Total Volume Inhaled (ml) 5,320 11,564 +117 

TPM (mg) 86 169 +97 

TPMKigarette (mg) 4.3 8.4 +95 

TPM/Puff (pg) 566 716 +27 

Phenol/Cigarette (pg) 12 30 +150 

GlyceroKigarette (pg) 327 1,212 +271 

Catechol/Cigarette (pg) 28 55 +96 

Hydroquinone/Cigarette (pg) 23 53 +130 

Nicotine/Cigarette (pg) 378 850 +125 

Neophytadiene/Cigarette (pg) 15 52 +247 

Palmitic Acid/Cigarette (pg) 35 86 +I42 

C,, AcidsKigarette (vg) 33 71 +115 

a Averaged, reported compensatoty smoking parameters (49-mL puff,38-second frequency, 2.5-secondpuffduration) 

set on smoking machine. 

Key: TPM = total particulate matter. 

Source: Schlotzhauer and Chorfyk, 1983. 

In a subsequent study of four popular king size cigarettes (see Table 6), 

Kozlowski (1981, p. 159) found that 

the same cigarette can easily rise from a low-tar to a high-tar 

category [through an increase in] the number of puffs taken 

from it, within the range of puffs per minute consistent with 

human smoking behavior. Based on the standard assay, brand 

B has 17 percent more tar than brand C; however, based on a 

10-puff estimate, their tar deliveries are identical. Those 

smokers who take 14 puffs per cigarette are getting 58 percent 

more tar than would be expected from the standard yields. 

Rawbone (1984), in a study of 400 middle-tar and low-tar smokers in 

the United Kingdom, found that tar delivery varied significantly between 

middle- and low-tar cigarettes but noticeably less than expected. That is, 

where a 46-percent lower tar delivery was expected with the low-tar 

cigarettes, a 32-percent reduction was observed. Furthermore, with regard 

to tar delivery, 98 percent of the middle-tar cigarette smokers fell within the 

established bounds of 16.50 to 22.49 mg delivery, whereas only 70 percent 

255 
Smoking and Tobacco Control Monograph No. 7 

Table 6 

Tar yields (mg) as a function of number of puffs taken by smoking machines 

Number of Puffs 

Branda 6 10 14 

A 13 18 21 30 

B 13 21 22 31 

CC 13 18 22 31 

DC 12 17 19 27 

Four of the most popular brands of king-size fiber cigarettes. 

Mean number of puffsfor the standard assay for these cigarettes: A, 8.6puffs; 6,9.3;C,8.1;0,8.9. 

These brands are mentholated. 

Source: Kozlowski, 1981. 

of the low-tar cigarette smokers were experiencing a delivery at or below 

the upper limit of 10.49 mg set for low-tar cigarettes (with 30 percent 

experiencing a higher-than-expected tar delivery). 

Rickert and colleagues (1986) machine-analyzed the nicotine, tar, and 

CO yields of 10 cigarette brands under 27 different conditions (the standard 

condition and 26 variations). Tar, nicotine, and CO yields increased with 

volume of smoke produced per cigarette, but yields per liter of smoke were 

relatively constant across the 27 conditions. 

Woodward and Tunstall-Pedoe (1992) investigated the smoking patterns 

of 2,754 smokers (1,133 males and 1,621 females) to determine intake of 

smoke components by smokers of low-tar cigarettes. This study, perhaps 

the largest naturalistic investigation of smoking behavior ever undertaken, 

included smokers of low-, middle-, and high-tar cigarettes. The researchers 

concluded that tar yield does not accurately reflect the amount of smoke 

components consumed by the smoker. Specifically, tar intake increased 

with tar yield but much less than anticipated; expired-air CO and cotinine 

seemed to peak among middle-tar smokers. For women, thiocyanate 

increased from low- to middle-tar smokers, and for men, from middle- to 

high-tar smokers. The researchers found that smokers of rniddle-tar cigarettes 

may consume more of some smoke components than smokers of high-tar 

cigarettes. Middle-tar smokers were noted to have higher Ievels of 

expired-air CO and cotinine. 

Armitage and colleagues (1988) investigated the influence of changes 

in tar yield when nicotine yield was maintained. Twenty-one smokers of 

middle-tar cigarettes were studied, with randomization to three categories: 

low tar and low nicotine, low tar and medium nicotine, and medium yields 

of tar and nicotine. With regard to nicotine uptake, there were no significant 

differences noted between middle-tar and nicotine-maintained cigarettes, but 

there were significant differences between low-tar and nicotine-maintained 

256 
Section IV 

cigarettes. The mean total puff volume of the nicotine-maintained cigarette 

was significantly greater than that recorded for middle-tar cigarettes. There 

was no difference in. mean total puff volume between low-tar cigarettes and 

nicotine-maintained cigarettes. 

RELATIVE YIELDS OF Ebert and colleagues (1983) undertook a study of 

DIFFERENT BRANDS BY 76 smokers to determine correlations between levels of 

TEE FIX TESTMETHOD plasma nicotine and alveolar CO and the nicotine and 

AND AMOUNT OF CO yields of cigarettes. The correlations were found to be 

NICOTINEABSORBED poor (Figures 1and 2). For the 24 smokers of low-nicotine, 

BY SMOKERS low-tar cigarettes, nicotine levels were statistically lower 

for smokers of low-nicotine cigarettes, but the levels were only slightly lower 

and there was great overlap in individual plasma nicotine values; there was 

no difference in the mean alveolar CO levels between the low-nicotine 

smokers and smokers of regular cigarettes. 

Research by Benowitz and colleagues (1983) on 272 subjects about to 

enter a smoking treatment program revealed that the correlation between 

stated nicotine yield and actual blood cotinine levels was not significant. 

Furthermore, it was determined that nicotine concentration in the unburned 

tobacco and amount of nicotine in an unburned cigarette are not correlated 

positively with FTC-determined yields and that tobacco in low-yield cigarettes 

did not contain less nicotine than tobacco in higher yield cigarettes. 

Figure 1 

Relationship between plasma nicotine concentration in smokers and nicotine yield 

of cigarettes smoked 

80 

70 

n

$ 60 \ 

P, = 50 

aJ 

S I

'3 40

.-s 

2 

i 30 

VI 

2 20 

p. 

10 

0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 t.8 

Nicotine Yield (mg) 

Source: Ebert et a/., 1983. 

25 7 
Smoking and Tobacco Control Monograph No. 7 

Figure 2 

Relationship between carbon monoxide (CO) concentration of alveolar air 

in smokers and CO yield of cigarettes smoked 

8091 

101 

I I I I I - 5 10 15 20 3 

CO Yield (mg) 

Source: Ebert et al., 1983. 

Ventilation and burning characteristics are the primary determinants of 

machine-measured yields, and these characteristics can be controlled by 

smokers. Benowitz and colleagues acknowledged that blood cotinine is not 

a “perfect marker,” but a full range of cigarettes was included in the study 

and there is no reason to suspect that brand is related to nicotine and 

cotinine metabolism. 

Russell and colleagues (1986) examined blood nicotine, cotinine, and 

carboxyhemoglobin (COHb) levels among 392 smokers whose regular brands 

varied from low tar to middle tar. Tar levels were estimated from blood 

nicotine levels and cigarette tar yields. The authors reported 

Smokers of LT [low-tar] cigarettes had a lower intake of tar, 

nicotine, and CO than the smokers of higher yielding brands. On 

average, their estimated intake of tar was about 25 percent lower, 

their intake of nicotine was about 15 percent lower (17 percent 

and 12 percent, as measured by blood nicotine and cotinine, 

respectively), and their intake of CO was about 10percent lower. 

These differences are substantially less than the reductions in the 

standard machine-smoked yields of their cigarettes (47 percent, 

39 percent, and 34 percent for tar, nicotine, and CO yields, 

respectively), and this indicates the extent to which the LT 

smokers were smoking and inhaling more intensively, presumably 

to compensate for the lower yields. However, it is clear that 

258 
Section IV 

despite such compensatory changes in smoking behavior, 

their intake of the three major smoke components was still lower 

to a statistically and clinically significant degree (Russell et al., 

1986, p. 83). 

Maron and Fortmann (1987) examined the relationship of FTC 

machine-estimated nicotine yield by cigarette brand with the level of 

cigarette consumption and two biochemical measures of smoke exposure 

(expired-air CO and plasma thiocyanate) in a population of 713 smokers. 

These investigators found that the lower the nicotine yield, the greater 

the number of cigarettes smoked per day. Smokers of ultralow-nicotine 

cigarettes experienced smoke exposures that were not significantly different 

from those of smokers of higher yield brands. Only after adjustment for 

number of cigarettes smoked daily did nicotine yield become significantly 

related to expired-air CO and plasma thiocyanate. The number of cigarettes 

smoked per day accounted for 28 and 22 percent of the variance in observed 

expired-air CO and plasma thiocyanate levels, respectively, whereas nicotine 

yield accounted for only 1and 2 percent of the variance, respectively. The 

authors concluded that machine estimates suggesting low nicotine yield 

underrepresent actual human consumption of harmful cigarette constituents. 

In a study of 289 smokers of cigarettes in the 1-mg FTC tar class, Gori 

and Lynch (1983) observed that nicotine intake (measured by plasma 

cotinine) varied widely, from undetectable to about 800 ng/mL. The 

findings indicated that smokers of low-yield brands tend to take in more 

nicotine than posted FTC values. This observation is illustrated in Figure 3. 

Brand A was .9 tar and .18 nicotine, whereas brand B was .5 tar and 

.10 nicotine. 

Coultas and colleagues (1993), working with a population of 298 mostly 

Hispanic smokers, studied the relationship between yields of cigarettes 

currently smoked and levels of salivary cotinine and expired-air CO. 

Spearman's correlation coefficients (Snedecor and Cochran, 1980) between 

the current number of cigarettes smoked and cotinine or CO were higher 

than correlations between the FTC nicotine data and these same markers. 

In multiple linear regression models, the current number of cigarettes 

smoked was the most important predictor of cotinine and CO levels 

(p < O.OOOl), and the addition of FTC tar, nicotine, and CO to the models 

explained little about the variability in cotinine and CO levels. 

In a large-scale study of 2,455 cigarette smokers who smoked their usual 

brands, Wald and colleagues (1984) observed that nicotine and CO intake 

was relatively constant across brands, regardless of stated yield, although tar 

intake appeared related to tar yield. 

YIELD BY THE FIX TEST As pointed out by many researchers, cigarette 

METHOD AND ABSORPTION smoking has the hallmarks of drug-dependent 

OF NICOTINE IN SWITCHERS behavior, with strong evidence that nicotine is 

the dependence-producing component (Benowitz et al., 1989). Nicotine is 

rapidly absorbed into the blood and quickly delivered to the brain, where 

259 
Smoking and Tobacco Control Monograph No. 7 

Figure 3 

Observed and expected baseline plasma cotinine values as a function of FTC 

nicotine delivery of brands A and B 

A Controls, male and female 

0

(SEMI

Brand A males 

(13.9)d

Brand A females

300 0 Brand B males 

Brand B females females 

n 

A (16.8)

E

& 200 

C (10.9) U 

al

C.-

.-C

CI 

0 

V 

i! 

m 

-

m

n 

100 

Q I 

0.1 0.2 

FTC Nicotine (mgkigarette) 

Key: SEM = standard error of the mean. 

Source: Gori and Lynch, 1983. 

it produces a range of mental effects on the smoker. This quick absorption 

and effect permit the smoker to control the nicotine level carefully; however, 

nicotine is rapidly eliminated from the body, which means the smoker has 

to deliver regular doses to the blood. 

260 
Section IV 

Robinson and colleagues (1982 and 1983) studied the smoking patterns 

of 22 cigarette smokers divided into treatment and control groups, with the 

treatment group switching twice to cigarettes of successively lower nicotine 

yields. Compensation behavior was measured noninvasively (average 

number of daily cigarettes, daily mouth-level nicotine exposure, butt length, 

expired-air CO, and saliva thiocyanate) and invasively (COHb, serum 

cotinine, and plasma thiocyanate). As shown in Figure 4, there were no 

major differences between smokers in treatment and control groups. The 

near-complete compensation was attributed to upward changes in smoking 

intensity, depth of inhalation, and cigarette consumption. In addition, there 

was an observed tendency of smokers of lower delivery cigarettes to smoke 

cigarettes down closer to the ovenvrap and to block ventilation holes. 

In a different approach, Gritz and colleagues (1983) looked at the puffing 

behavior of eight smokers presented with cigarettes at two and four times 

Figure 4 

Average daily exposure and standardized exposure measures by period for treatment and 

control groups 

mCC'B-hco I D' sa'iva mi-nats

I0l 2ol 10 1,0001 5 lot

u uu.- +,- -P2- -Pa- 4,- -P,- -Ps- +,- -P2- -Pa-- 4,- -P2- -P,-

Period Period Period Period 

F. SiandardlrsdBraam M

.4 c

+,- -P2- -Pa- 4,- -P2- -P3-

Period Period 

Note: Average nominal nicotine deliveries are shown as horizontal lines in Panel H. Abbreviated variable names have 

been used. The increase of "standardized exposure measure for the treatment group (Panels F and G) during 

period three (PJ does not represent an increase in exposure. The exposure remains fairly constant during the 

entire study, as Panels Cand D indicate. Panels F and G illustrate the extent of compensation necessary to 

maintain this constant exposure. See text for details. 

Key: MLE = mouth-level exposure; CO = carbon monoxide. 

Source: Robinson et al., 1982. 

261 
Smoking and Tobacco Control Monograph No. 7 

their normal smoking rates. All eight smokers compensated to some degree. 

Despite being presented with twice the usual number of cigarettes, the 

smokers titrated their nicotine intake down, largely by changing their number 

of puffs, puff volume, and puff duration per cigarette. Gritz and coworkers 

disputed the view that some smokers may be compensators and others may 

be noncompensators, arguing that these two groups of smokers represent the 

opposite ends of a continuum. 

Henningfield and Griffiths (1980) studied the effect of tobacco product 

concentration on puffing rate and total number of puffs. Tobacco 

concentration levels were set at 100, 50, 25, and 10 percent by means of 

ventilated holders (identified in Figures 5 and 6 as holders 0, 1,2, and 4). 

As shown, puffs at holder 4 were about double those of holder 0. In addition, 

there were substantial increases in puff rate. 

Compensation via alterations in puffing patterns does not explain all 

observed changes, however. In their investigation of puffing and inhalation 

patterns and yields, Nil and colleagues (1986) found that changes in puff 

volume account for only about one-fifth of the difference in smoke yields; 

no significant changes were found in inhalation patterns. On the other hand, 

with lower yield cigarettes, there was nearly complete compensation based 

on alveolar CO uptake, and the degree of increased heart rate was viewed 

as a nearly complete compensation for nicotine intake. 

McBride and colIeagues (1984) measured changes in smoking behavior 

and ventilation when subjects smoked cigarettes of varying nicotine yields. 

Nine smokers were studied, and the test order was randomized. Puff volume 

was noted to increase significantly during the smoking of low-nicotine 

cigarettes. In a study of 170 male smokers and 170 age-matched male 

nonsmokers, Bridges and colleagues (1986) observed that total puff volume 

was significantly greater for smokers of cigarettes lower in nicotine yields. 

As shown in Figures 7 and 8, total puff volume was significantly correlated 

with nicotine yield and plasma cotinine. 

Researchers have observed that smokers can substantially alter tar, 

nicotine, and CO delivery of cigarettes by blocking the ventilation holes in 

the filters. In a two-part study of smokers of low-yield cigarettes, Kozlowski 

et al. (1982a) observed hole-blocking behavior and measured tar, nicotine, 

and CO levels. The investigators reported that 44 percent of 39 smokers of 

low-yield cigarettes blocked the ventilation holes to various degrees with 

their fingers or lips; 5 of 33 females left hole-blocking lipstick on the filters. 

In the second part of their study, Kozlowski and colleagues (1982a) 

evaluated the effect of hole blocking on the tar, nicotine, and CO yields of 

American, British, and Canadian cigarettes of lowest or near-lowest yields. 

AfteI videotaping 48 smokers, the researchers defined actual smoking 

behaviors and reset smoking machine parameters to reflect these real-life 

patterns for puff interval (44 seconds) and puff duration (2.4 seconds). 

Machine puff volume was set at 47 mL (2 to 13 mL below the smokers' 

estimated average) because this is the maximum obtainable from most 

262 
Section IV 

Figure 5 

Mean total puffs per session (N= 4) and standard error values for each subject as 

a function of cigarette holder number 

t 

I I I 0’ I 

0 1 2 4 

Ventilated Holder 

Note: The approximate concentrations of delivered tobacco product are indicated by the holder 

number in which 0 = 100percent, 1 = 75 percent, 2 = 50 percent, and 4 = 10 percent. The 

abbreviations ST, ED, and GR represent three paid female volunteers who participated in the 

study. 

Source: Henningfield and Griffiths, 1980. 

machines. Ventilation holes were blocked with tape. The researchers 

compared standard yields of cigarettes to yields resulting from the studydetermined parameters and blocked ventilation holes; they observed that 

“tar increases from 15-to 39-fold, nicotine from 8-to 19-fold and CO from 

10-to 43-fold” (Kozlowski et al., 1982a, p. 159). Five cigarette brands similar 

in tar yield were found to differ substantially when parameters were changed 

and holes blocked. 

In a later study of 14 subjects, Kozlowski (1989) detected hole blocking 

by half the sample. Subjects blocking the ventilation holes of ultralow-yield 

263 
Smoking and Tobacco Control Monograph No. 7 

Figure 6 

Mean number (N= 4) of cigarettes smoked by each subject during 3-hour sessions 

as a function of holder number (upper frame) and mean rate of puffing (puffs/ 

minute) per cigarette (lower frame) 

81 1 

mH 

ED T 

GR 

0’ I I I I 1 

T 

I I I I 

0 1 2 4 

Ventilated Holder 

Note: Standard error values for each subject, in both frames, are indicated by the brackets. The 

approximate concentrations of delivered tobacco product are indicated by the holder number in 

which 0 = 100percent, 1= 75percent, 2 = 50 percent, and 4 = 10percent. The abbreviations 

ST, ED, and GR represent three paid female volunteers who participated in the study. 

Source: Henningfield and Grifiths, 1980. 

264 
Section IV 

Figure 7 

Relationship of total puff volume per cigarette with the nicotine yield of the 

cigarette smoked 

Y 

y = -485.0~+ 1,023 

g 2,000 r = -0.407 

1,800 p = 0.0001 

f 1,600

6

Q 1,400 

1,200 

2 1,000 

800 .. 5 600 n a .....--- -(0 400 .a aI

t - *.. - w 

... 2 200 

... I 1 I I $ 1 1 1 1 1 - , 1 I c x_. 0.1 0.20.30.40.50.60.70.80.9 1.0 1.1 1.2 

Nicotine Yield (mgbigarette) 

Source: Bridges et a/., 1986. 

Figure 8 

Relationship between plasma nicotine concentration and total volume puffed 

per cigarette in a population smoking a single brand of cigarette (nicotine yield = 

1.05 mgcigarette) 

y = 0.0282~+ 11.77 

60 - r = 0.424 

55 - p = 0.02 

F;

50 

35 -

30 - . 25 - a

20 -

15-. .. . . . - 10

5t, 0 : X I I I I I I I I I I I I ~ 

240 360 480 600 720 840 960 1,080 

Total Puff Volume/Cigarette (mL) 

Source: Bridges et a/., 1986. 

265 
Smoking and Tobacco Control Monograph No. 7 

cigarettes were found to have higher CO and salivary cotinine levels. 

Rickert and colleagues (1983) found that blocking half the ventilation holes 

increased the delivery of TPM by 60 percent, aid full occlusion increased 

TPM delivery by 150 percent. 

The effect of blocking on perforation ventilation (ventilation holes in the 

filter) and channel ventilation (longitudinal air channels around the filter) 

was studied by Hofer and colleagues (1991). The researchers compared 

results of lip smoking and holder smoking of cigarettes among 72 smokers, 

divided equally by ventilation type of cigarette smoked. Hofer and 

colleagues (1991, p. 910) found that 

under normal lip contact conditions, the CO and nicotine 

deliveries of the channel-ventilated cigarettes were higher than 

those of the perforation-ventilated cigarettes and higher than 

with holder smoking. With holder smoking, both types of 

cigarettes delivered comparable amounts of CO and nicotine 

(t-tests, n.s.). 

It appeared that the nicotine boost from channel-ventilated cigarettes was 

twice that of perforation-ventilated cigarettes; differences in CO exposure 

were less well defined. The researchers judged that there was evidence 

of blocking in 86 percent of the channel filter cigarette smokers and in 

33 percent of the perforated filter cigarette smokers. 

In a novel approach to the study of hole blocking among smokers 

of ultralow-tar cigarettes, Kozlowski and colleagues (1988) collected 

135 discarded filters from ashtrays in shopping malls. It was found that 

58 percent of the filters showed some evidence of hole blocking (as measured 

by tar stain patterns); 19 percent showed evidence of extreme hole blocking; 

and 42 percent showed no signs of hole blocking. Kozlowski and colleagues 

(1994) extended this research to “light” cigarettes (about 9 to 12 mg tar, 

about 15 to 30 percent vented): Twenty-seven percent of collected filters 

indicated extreme blockage; 26 percent showed some blocking; and 

47 percent showed no vent blocking. Although defeat of the air vents 

will have a relatively small effect on light rather than ultralight cigarettes, 

the greater sales of light cigarettes contribute to its significance for public 

health. In an earlier report, Kozlowski and colleagues (1980b) examined 

the effect of hole blocking on nicotine, tar, CO, and puffs (Table 7), noting 

that ventilated filters have been developed primarily as a way to make less 

toxic cigarettes but that smoking behavior can sabotage the benefits of 

these filters. 

Kozlowski and colleagues (1989) demonstrated that some smokers of 

vented filter cigarettes are lighter smokers who appear to be seeking lower 

smoke doses and do not block vents, whereas others are generally heavier 

smokers who block vents and derive high daily doses of nicotine. Two 

smokers, who were vent blockers, of a 1-mg tar, 0.1-mg nicotine cigarette 

achieved salivary cotinine levels (303 and 385 ng/mL) consistent with 

smoking a high-yield cigarette. 

266 
Section IV 

Table 7 

Effects of blocking the ventilation holes on the yields of a popular, low-yield cigarettea 

Unblocked Half-Blocked Fully Blocked 

Characteristics Holes Holes Holes 

Constituents 

Nicotine (mg) 0.45 0.73 f .06 0.98& .06a 

Tar (mg) 4.40 7.03 2 .04 12.60 2 .20a 

Carbon Monoxide (rng) 4.50 7.80 -e .24 17.70 2 .40a 

Puffs 11.10 10.50 -e .20 9.20 2 .40a 

a Half-blocked vs. fully blocked comparison (t-test, Ptailed) p e .01. Values are means f standard deviations. 

Government figures for the June-July 1979 assay were used as the unblocked control; variances were not reported, 

but those found in similar analyses imply that all within-row comparisons would be statistically significant. AI1 

analyses in the table were performed by the same laboratory employing the same techniques. 

Source: Kozlowski et ab, 198Ob. 

Bridges and colleagues (1990) studied 170 male smokers to determine 

the influence on yield of smoking topography (i.e., total smoking time per 

cigarette, number of puffs, interpuff interval, puff duration, volume per puff, 

total duration per cigarette, total volume per cigarette, flow rate). The 

smokers were divided into six groups according to stated nicotine yields 

of their cigarettes. The first four groups were most similar in age, smoking 

history, and alcohol and coffee consumption. There were significant 

negative correlations between nicotine yield and mean puff volume, total 

duration and volume, and flow rate. That is, as nicotine yield decreased, 

mean puff volume, total duration and volume, and flow rate increased 

significantly. These statistical relationships are shown in Figure 9. Multiple 

regression analysis showed that nicotine yield, alone or in combination with 

other factors, is a significant predictor of number of puffs or total puff 

volume per cigarette. 

Figure 9 is of special interest because it represents smoking topography 

changes in a subpopulation for which nicotine yield was held constant 

to control for the possible confounding effects of nicotine on smoking 

behavior. Cumulative puff volume for a cigarette is significantly correlated 

with plasma nicotine, an indication that increased inhalation results in 

increased absorption. For the same group, the interpuff interval was 

negatively correlated with plasma nicotine levels (i.e., when time between 

puffs went down, plasma nicotine level went up). 

According to Bridges and colleagues (1990, p. 31) 

Smokers smoking the lowest yield cigarettes (Group 1)had 

significantly higher total puff volume per cigarette than did the 

other groups, and significantly higher mean puff volume and 

flow rate . ..than Groups 3 and 4. Smokers of lower yield 

267 
Smoking and Tobacco Control Monograph No. 7 

Figure 9 

linear relationships between nicotine yield and puffing topography measures: 

(A) number of puffs per cigarette, (B) total puff duration per cigarette, (C)total 

puff volume per cigarette 

Y 

30 .A y = 4.076~+ 13.71 

28 r = 4.163 

p = 0.09 2 26. 

$ 24. 

ca 22 s 20 

f 18 n

6 16 

& 14 

;

12 

10 . - 8 

- .. - .- . - .. 

.. . 

. -.-

61 .. 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 

Nicotine Weld (mucigarette) 

V 

B y I -11.84~+ 31.99 

r = 4.282 

p=o.m 

0 45 0

5 40-

-x 35- - .. 2

- . . .. .-.P : 3 15- .. - .. . .-. 

+ 10 - .. -P-: 4' * a I I I I I I I t m'-X 

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 

C y = 485.m+ 1.023

3 - r = 4.407

E 2,000 

;1,800 - p = 0.m1 

5 1,600 - E' 1,400-

Y E - 1,200 

$ 1,000 - > 

5 

600 -

400- . ..- ---.

-... 200 -

, . n o 0 , * ~ ~ x . 1 

268 
Section IV 

cigarettes also tended to have higher numbers of puffs per 

cigarette, decreased interpuff interval, increased duration per 

puff, and increased duration per cigarette, but these differences 

did not reach statistical significance. These results are consistent 

with changes in puffing topography to compensate for lower 

yield cigarettes . 

In addition, there were significant negative correlations between 

nicotine yield and mean puff volume, total duration and volume, and flow 

rate. That is, as nicotine yield decreased, mean puff volume, total duration 

and volume, and flow rate increased significantly. In addition, multiple 

regression analysis showed that nicotine yield, alone or in combination 

with other factors, is a significant predictor of number of puffs or total puff 

volume per cigarette. 

Creighton and Lewis (1978) examined changes in smoking patterns 

when cigarettes were varied according to nicotine delivery. Specifically, 

16 smokers were monitored for 3 months. The first month, they all smoked 

medium-delivery cigarettes of about 1.4mg nicotine; then the group was 

split for 1 month, with half smoking lower delivery cigarettes (about 

1.0 mg nicotine) and half smoking higher delivery cigarettes (about 1.8mg 

nicotine). During the third month, the panel of 16 smokers returned to 

the 1.4 mg nicotine cigarettes. Significant changes were found in smoking 

patterns among the 16 smokers: either the increased smoking intensity 

when smoking lower delivery cigarettes or decreased intensity when smoking 

higher delivery cigarettes. However, the researchers reported that the 

smokers did not equalize nicotine and TPM delivery when they switched 

to lower delivery cigarettes, as was the case when they switched to higher 

delivery cigarettes. The number of cigarettes smoked per day remained 

about the same throughout the study. 

Russell and colleagues (1982) looked at changes in nicotine, cotinine, 

COHb, thiocyanate, and tar when 12 smokers switched to low-tar, lownicotine cigarettes for 12 weeks. Plasma nicotine and cotinine were both 

reduced by about 30 percent and tar by 15 percent; plasma thiocyanate 

and COHb did not change significantly. Although mouth level of nicotine 

intake from low-tar, low-nicotine cigarettes was similar to the standard 

machine yield, the blood levels of 30 percent were substantially less than 

the anticipated level of 46 percent based on machine yields. There was 

no compensatory increase in smoke intake at the mouth level, but blood 

measures showed the increase in inhalation between 32.1 and 40.8 percent. 

Similarly, Ashton and coworkers (1979) found that, when switched from 

medium- to high- or low-nicotine brands, smokers compensated for about 

two-thirds of the difference in standard yields. Specifically, when nicotine 

yield was reduced by 50 percent, nicotine intake was about 15 percent lower. 

Furthermore, based on machine yields, it was anticipated that the nicotine 

yield of low-nicotine cigarettes would be 32.6 percent that of high-nicotine 

cigarettes; however, in the laboratory the observed yield was 59 percent that 

of high-nicotine cigarettes. 

269 
Smoking and Tobacco Control Monograph No. 7 

Benowitz and colleagues (1986) looked at differences in tar, nicotine, 

and CO exposure when smokers switched from their regular brand to high-, 

low-, and ultralow-yield cigarettes. The researchers detected no differences 

in exposure among the high- and low-yield smokers. However, for smokers 

of ultralow-yield cigarettes, there were substantial reductions in exposure to 

tar (49 percent), nicotine (56 percent), and CO (36 percent). Despite these 

reductions, the investigators reported that the relative exposure to tar and 

nicotine from ultralow-yield compared with higher yield cigarettes was much 

greater than predicted by FTC machine-determined yields. 

Kolonen and colleagues (1991) examined puffing patterns of 36 smoking 

students, with different smoking histones, in a natural environment. The 

subjects included 18 smokers of low-yield cigarettes, 10 smokers of mediumyield cigarettes, and 8 smokers who had switched from medium- to low-yield 

cigarettes. Subjects smoked their regular brand for the first week, a low-yield 

brand for the second week, and a medium-yield brand for the third week. 

All three groups had the highest daily puff volumes when smoking low-yield 

cigarettes, and the correlations between urine cotinine concentration and 

daily puffing in the three groups were poor. However, the urinary cotinine 

concentration was significantly lower for low-yield smokers compared with 

the switchers. The investigators concluded that cotinine excretion results in 

the switchers’ group were in line with earlier reports showing that long-term 

switchers have no significant decreases in plasma and urine cotinine. 

In a longer study of switching effects, Guyatt and coworkers (1989b) 

monitored 28 smokers who switched to cigarettes with lower tar and nicotine 

yields. The researchers concluded, after monitoring subjects for about 

1year, that most effects of the switch to lower yield cigarettes did not persist 

beyond 36 weeks. The drop in cotinine levels was only 40 percent of what 

was expected from stated nicotine yields; mean puff volume increased by 

16 percent; and smokers seemed to achieve about 60 percent compensation 

when smoking lower tar cigarettes. 

YIELDS BY THE ITC Carbon monoxide yields follow somewhat surprising 

TEST METHOD AND OTHER dynamics. For example, as Rickert and colleagues 

CONSTITUENTS USING (1980) reported, efficient filters may substantially 

FTC PUW PROFILE reduce tar yields of cigarettes but lead to increased 

delivery of CO. 

In a study of reduced-draw-resistance cigarettes, Dunn (1978) found that 

smokers can substantially vary their inhalation patterns, leading to marked 

changes in the amount of smoke that reaches the lungs as measured by 

alveolar CO levels. Although increased levels of alveolar CO were expected 

with reduced draw resistance, CO levels decreased, possibly because of 

increased delivery of nicotine. Dunn proposed that the level of CO in 

exhaled air may be a good measure of depth of inhalation. 

There appears to be substantial natural variation in the amount of 

CO inhaled by smokers, even when numbers of cigarettes smoked are 

approximately equal. Burling and colleagues (1 985) studied 12 matched 

270 
Section IV 

pairs of smokers, each pair smoking a similar number of cigarettes but with 

different levels of CO (one high-CO-level subject and one low-CO-level 

subject). The CO boost per cigarette was found to be significantly different 

for the matched pairs of smokers. The CO boost for the high-CO group was 

6.9 ppm per cigarette and for the low CO group 4.4 ppm. 

The study found no differences between the high-CO and low-CO groups 

in terms of number and duration of puffs. Given the significant differences 

in CO levels, the researchers speculate that the difference may reside in puff 

intensity, puff volume, or inhalation characteristics. These influences on CO 

levels are relevant to low-nicotine yields and changes in smoking behavior; 

Herning and colleagues (1983) reported that CO boost appears correlated to 

blood nicotine levels. 

In an earlier study, Burling and coworkers (1983) found that a smoker’s 

CO level is influenced by factors other than the FTC-determined CO yield 

of cigarettes. The researchers reported that the CO level is significantly 

related to interpuff interval, cigarette duration, time since last cigarette, and 

self-rated estimate of depth of inhalation. This research underscores the 

likelihood that CO levels may be determined by multiple factors, not just 

stated yield. However, the finding suggests that, when numbers of cigarettes 

are held equal, a person smoking cigarettes with a higher CO yield will likely 

have higher CO levels than a person smoking cigarettes of lower CO yield. 

Furthermore, Wald and colleagues (1984) reported that smokers of filter 

cigarettes have a 60-percent higher intake of CO than do those who smoke 

nonfilter cigarettes. 

Russell and colleagues (1982), in a study of long-term switching to lowtar, low-nicotine cigarettes, observed complete compensation as measured by 

CO uptake, and Robinson and coworkers (1983) reported that COHb levels 

did not change significantly after smokers switched to cigarettes with 15-and 

72-percent lower CO deliveries. 

Robinson and colleagues (1984) examined exposure among 22 smokers 

of high-nicotine cigarettes who switched to cigarettes of similar nicotine 

yield but with reduced yields for tar, CO, and hydrogen cyanide. Cotinine 

levels remained about the same; however, although reductions of 40 to 

50 percent in CO and HCN were expected, the measured reductions were 

5.3 percent for expired-air CO, 12.2 percent for COHb, 2 percent for saliva 

thiocyanate, and 1percent for plasma thiocyanate. 

Darrall (1988) found that a 50-percent blockage of ventilation holes 

produced small changes in tar and nicotine yields but greater changes in CO. 

Nil and coworkers (1986), in a study of 117 regular smokers, reported that 

the CO boost of cigarettes appeared to remain steady among smokers despite 

controlled switching to cigarettes of higher or lower yields. 

Fischer and colleagues (1989), in an investigation of six different 

cigarette brands (filter and nonfilter and very low to medium tar yields), 

found that puff volume and puff frequency, the key determinants of total 

271 
Smoking and Tobacco Control Monograph No. 7 

volume inhaled, significantly affect the smoker’s exposure to tobacco-specific 

nitrosamines. According to the investigators, 

The medium-tar cigarette using standard smoking conditions 

delivered TSNA values that were close to the calculated average 

intake by smokers. The calculated average TSNA intake for the 

low-tar cigarette, however, was about double the value determined 

under standard smoking conditions (Fischer et ai., 1989, p. 1065). 

The researchers concluded that 

since the standard smoking conditions cannot reflect the real 

behavior for low- and very-low-tar cigarettes, especially with 

respect to the total inhalation volume, risk evaluation has to 

consider the increase in TSNA intake with increasing total 

volume (Fischer et al., 1989, p. 1065). 

In a subsequent study, Fischer and colleagues (1991) investigated 

170 types of American, European, and Russian cigarettes. The findings 

revealed that the amounts of two TSNAs-NNN (N-nitrosonornicotine) 

and NNK (4-methylnitrosamino-1-[3-pyridinyl]-1-bu tanone)-in cigarette 

smoke are not correlated with tar or nicotine delivery and the amounts of 

TSNAs in mainstream smoke are related to the amount of preformed 

nitrosamine in the tobacco. 

In an investigation of compensation behaviors among smokers switching 

to lower delivery cigarettes, Robinson and coworkers (1983) noted 

disproportionate increases in HCN levels. The researchers concluded that 

machine-determined “standardized” deliveries do not reflect potential 

exposure to HCN. 

Rickert and Robinson (1981), in a study of delivery by low-hazard and 

high-hazard brands and actual levels, found that differences in HCN and 

CO yields of the two different delivery types varied much more widely than 

actual levels of COHb and plasma thiocyanate obtained from smokers of 

each. High-hazard cigarette smokers had nearly four times the HCN of 

low-hazard cigarette smokers; however, the actual levels differed by only 

20 percent. These differences were not statistically significant, possibly 

due to small sample size (n = 31). 

Rickert and colleagues (1983) looked at variations in smoking patterns 

and reported that HCN delivery is influenced by blocking of ventilation 

holes and, to a lesser degree, by puff duration, puff volume, and butt length. 

Blocking half the ventilation holes increased HCN yield by 70 percent; 

covering all the holes produced a 250-percent increase in yield. These 

investigators determined that HCN yield for the cigarette brand investigated 

ranged from 5 to 241 pg, depending on variations in smoking parameters, 

although the mean HCN yield was 39 pg. For 115 Canadian cigarettes, the 

average HCN yield varied from 2 to 233 pg. This impact of smoking pattern 

on HCN yield was cited by Rickert and colleagues as a possible explanation 

272 
Section IV 

for the poor correlation between HCN yield and levels of plasma thiocyanate 

and saliva thiocyanate. 

Rickert and colleagues (1980) indicated that aldehydes, gas-phase 

constituents of tobacco smoke, are known to be ciliatoxic and may not be 

removed to a substantial degree from cigarette smoke by filters. Acrolein, a 

toxin restricted in occupational and industrial settings, also may contribute 

to the chemical toxicity of tobacco smoke. In a study of 102 brands of 

Canadian cigarettes, Rickert and colleagues found that tar level was a poor 

predictor of total aldehydes and acrolein delivery. The effect of changes in 

smoking patterns on phenol, glycerol, catechol, hydroquinone, palmitic acid, 

and neophytadiene are shown in Tables 2 through 5 (Schlotzhauer and 

Chortyk, 1983). 

PROPOSALS TO At least three proposals have been published for changes in the 

CHANGE THE FlX ETC cigarette test method. Kozlowski and colleagues (1982b) 

TEST METHOD made a proposal addressing the issue of the variability in human 

smoking behavior. These investigators suggested a three-level (Le., light, 

average, and heavy) machine regimen linked to a color-matching technique 

to help smokers gauge the extent of puffing on a given cigarette-the darker 

the stain, the greater the exposure, with the tar stains keyed to a range 

of tar doses. Rickert and colleagues (1986) proposed an estimate based 

on average yields of tar, nicotine, and carbon monoxide per liter of smoke. 

Henningfield and coworkers (1994) proposed that multiple tests be used: 

an average smoking test and a heavy smoking test. The heavy smoking test 

would include vent-blocking conditions for those cigarettes incorporating 

ventilation holes and if it is possible for those holes to be blocked by the 

smoker’s lips or fingers. 

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