[Federal Register Volume 62, Number 177 (Friday, September 12, 1997)]
[Notices]
[Pages 48158-48163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24246]


      

[[Page 48157]]

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Part III





Federal Trade Commission





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Cigarette Testing; Request for Public Comment; Notice

  Federal Register / Vol. 62, No. 177 / Friday, September 12, 1997 / 
Notices  

[[Page 48158]]



FEDERAL TRADE COMMISSION


Cigarette Testing; Request for Public Comment

AGENCY: Federal Trade Commission.

ACTION: Request for public comment on proposed revisions to the Federal 
Trade Commission methodology for determining tar, nicotine, and carbon 
monoxide yields of cigarettes, and a proposed format for disclosing the 
resulting ratings in advertising.

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SUMMARY: The Federal Trade Commission (``FTC'' or ``Commission'') is 
soliciting comments on proposed revisions to the testing method used to 
determine the tar, nicotine, and carbon monoxide ratings of cigarettes, 
and the disclosure of those test results.

DATES: Written comments must be received by November 17, 1997.

INSTRUCTIONS: Six paper copies of each written comment should be 
submitted to the Office of the Secretary, Federal Trade Commission, 
Room 159, Sixth Street and Pennsylvania Avenue, N.W., Washington, D.C. 
20580. To encourage prompt and efficient review and dissemination of 
the comments to the public, all comments also should be submitted, if 
possible, in electronic form, on either a 5\1/4\ or a 3\1/2\ inch 
computer diskette, with a label on the diskette stating the name of the 
commenter and the name and version of the word processing program used 
to create the document. (If possible, documents in WordPerfect 6.1 or 
Word 6.0, or earlier generations of these word processing programs, are 
preferred. Files from operating systems other than DOS or Windows 
should be submitted in ASCII text format to be accepted.) Submissions 
should be captioned: ``FTC Cigarette Testing Methodology,'' FTC File 
No. P944509.

FOR FURTHER INFORMATION CONTACT: Shira D. Modell, Division of 
Advertising Practices, Federal Trade Commission, Sixth Street and 
Pennsylvania Avenue, N.W., Washington, D.C. 20580, (202) 326-3116.
SUPPLEMENTARY INFORMATION: Cigarette ratings for tar, nicotine, and 
carbon monoxide are determined through testing conducted pursuant to 
what is generally referred to as the ``FTC cigarette testing 
methodology'' or, more simply, the ``FTC method''--a reference to a 
smoking machine testing protocol that the Commission adopted in 1967.
    The Commission is seeking comment on proposed changes to that 
methodology. The proposed methodology would require that each cigarette 
variety be tested under two different sets of smoking conditions, 
rather than the single set used under the current system. The revised 
test method would produce tar, nicotine, and carbon monoxide yields 
using both the current testing parameters and more intensive smoking 
conditions, thus producing a range of potential yields for each 
cigarette. In addition, the Commission is requesting comment on the 
feasibility of generating the upper tier of tar, nicotine, and carbon 
monoxide ratings through mathematical formulas, rather than actual 
testing on a smoking machine. The Commission is also placing on the 
public record two different legends that could be used in advertising 
to disclose the ratings and is seeking comment on the usefulness and 
feasibility of these potential disclosure formats. Finally, the 
Commission is requesting comment on alternative approaches that were 
considered but are not being proposed by the Commission.

I. Cigarette Testing Methodology

A. History and Purpose of the Current Test Method

    The current FTC system for tar and nicotine testing is an outgrowth 
of the Commission's authority to prohibit deceptive or unsubstantiated 
claims in advertising. See 15 U.S.C. 45. The Commission's earliest 
involvement in this area was in cases addressing competing tar and 
nicotine claims in cigarette advertising. One problem with these early 
claims was that the tar and nicotine numbers reported by different 
manufacturers were obtained using varying methodologies, and therefore 
were not comparable. In 1966, to provide a uniform basis for 
advertising claims, the Commission authorized establishment of a 
laboratory to analyze mainstream cigarette smoke (i.e., the smoke that 
is drawn through the cigarette rod during puffing), 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.1
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    \1\ 31 FR 14278 (Nov. 4, 1966). The Cambridge Filter Method had 
been described in Ogg , Determination of Particulate Matter and 
Alkaloids (as Nicotine) in Cigarette Smoke. 47 J. Ass'n. Official 
Agric. Chemists 356 (1964), although the actual parameters appear to 
have been identified 30 years earlier by researchers for The 
American Tobacco Company.
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    The Commission's cigarette testing laboratory began operation in 
1967.2 The testing methodology adopted by the Commission 
called for cigarettes to be smoked by a smoking machine that was 
calibrated to take one puff of two seconds' duration and 35 milliliters 
volume every minute. Cigarettes were to be smoked to a butt length of 
23 millimeters or the length of the filter and overwrap plus 3 
millimeters, whichever was longer. One hundred cigarettes of each 
variety were to be smoked to determine the tar and nicotine 
ratings.3
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    \2\ 32 FR 11178 (Aug. 1, 1967).
    \3\ Testing for carbon monoxide was added to the protocol in 
1980.
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    In 1970, the Commission proposed a trade regulation rule that would 
have required disclosure of tar and nicotine ratings in all cigarette 
advertising.4 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 disclose 
clearly and prominently the ratings produced by the Commission's 
protocol in certain types of advertising. That voluntary agreement, 
modified to reflect the closing of the Commission's laboratory in 1987, 
remains in effect today, and it forms the basis for current disclosure 
of tar and nicotine yield.5
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    \4\ 35 FR 12671 (Aug. 8, 1970).
    \5\ In early 1987, the Commission decided to close its cigarette 
testing laboratory. Since then, most of the tar, nicotine, and 
carbon monoxide ratings reported by the Commission are determined 
through testing conducted by the Tobacco Institute Testing 
Laboratory using the Commission's testing parameters. Thus, although 
some changes have been made, the modified Cambridge Filter Method 
adopted by the Commission in 1967 remains essentially in place 
today.
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    The Commission's test method was not designed ``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 a machine in accordance with the prescribed method.'' 
6 The purpose of the program was to provide smokers seeking 
to switch to lower tar cigarettes with a single, standardized 
measurement with which to choose among the existing brands.7 
This goal was consistent with the then-consensus of the scientific 
community that lower tar and nicotine cigarettes should be less harmful 
than higher tar and nicotine brands.8
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    \6\ FTC Press Release--Statement of Considerations 2 (Aug. 1, 
1967).
    \7\ Indeed, since the adoption of the FTC test method, the 
sales-weighted average tar rating of cigarettes sold in the United 
States has declined from 21.6 mg. in 1968 to 12.1 mg. in 1994. 
Federal Trade Commission, Tar, Nicotine and Carbon Monoxide of the 
Smoke of 1206 Varieties of Domestic Cigarettes for the Year 1994 
Table 1 (1997).
    \8\ The year before the Commission's laboratory began cigarette 
testing, 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. Dept. of Health and Human Services, The Health 
Consequences of Smoking: The Changing Cigarette at 1 (1981) (quoting 
1966 Public Health Service statement).

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[[Page 48159]]

B. Current Concerns About the FTC Cigarette Testing Methodology

    Changes in cigarette design and increased knowledge about human 
smoking behavior have highlighted the limitations of the existing test 
method. In particular, research indicates that smokers switching to 
cigarettes at the lower end of the range of machine measured nicotine 
yields tend to take larger and more frequent puffs to satisfy their 
need for nicotine. This compensatory smoking behavior substantially 
reduces the informative value of the current ratings. As a result, 
public and private health groups and others have questioned the 
usefulness of the FTC ratings over the past few years, suggesting that 
they may mislead consumers with respect to the relative risks of 
smoking cigarettes with various levels of tar and nicotine ratings.
    The Commission has been especially concerned that some consumers 
may believe that the existing machine measured yields are literal 
indicators of how much tar and nicotine they will get from particular 
brands of cigarettes. To the extent that smokers interpret current tar 
and nicotine disclosures in this manner, they may fail to understand 
that the amount of tar and nicotine they get from a cigarette depends 
in part on how that cigarette is smoked. In addition, smokers--
especially those who engage in compensatory smoking--may underestimate 
the risk associated with lower rated brands by assuming that a very low 
tar yield necessarily translates into a correspondingly low health 
risk. In fact, even the lowest rated cigarette represents an important 
adverse health risk.

C. National Cancer Institute Conference: Its Conclusions and 
Recommendations for the FTC Cigarette Testing Methodology

    In July 1994, due to many of these same concerns, the Commission 
requested that the National Cancer Institute (``NCI'') convene a 
consensus conference to address certain issues concerning the FTC's 
cigarette testing methodology and ratings system. On December 5 and 6, 
1994, NCI conducted the requested conference before an Ad Hoc Committee 
of the President's Cancer Panel.
    The Ad Hoc Committee heard presentations on such issues as changes 
in cigarette design over time, attitudes and beliefs about low-yield 
cigarettes, the relationship between tar and nicotine yields and the 
incidence of smoking related diseases, and smokers' perceptions of the 
meaning of the ratings produced by the current test method. Before 
adjourning, the Ad Hoc Committee issued a summary of its conclusions 
and recommendations.9 The Committee concluded that 
significant changes should be made to the current FTC protocol and 
specifically reached the following conclusions, among others:
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    \9\ The proceedings of that conference have been published by 
the National Institutes of Health. Smoking and Tobacco Control 
Monograph 7--The FTC Cigarette Test Method for Determining Tar, 
Nicotine, and Carbon Monoxide Yields of U.S. Cigarettes: Report of 
the NCI Expert Committee (1996) (``NCI Monograph'').

    I. * * *
    A. The smoking of cigarettes with lower machine-measured yields 
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-
measured tar yield from 15 mg. to 1 mg. tar does not reduce relative 
risk from 15 to 1.
    B. The FTC 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 U.S.
    2. This information should be clearly communicated to smokers.
* * * * *
    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.
* * * * *
    F. The system should be re-examined at least every five years to 
evaluate whether the protocol is maintaining its utility to the 
smoker.
* * * * *
    II. [T]he committee recommends that in order to avoid confusing 
smokers, no smoke constituents other than tar, nicotine and carbon 
monoxide be measured and published at the present time. * * *
    III. * * *
    C. The available data suggest that smokers misunderstand the FTC 
test data. This underscores the need for an extensive public 
education effort.10
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    \10\ NCI Monograph at vi-viii.
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D. The Proposed New Method

    Consistent with the Ad Hoc Committee's conclusion that a ratings 
range would provide superior information to consumers than the unitary 
ratings generated by the current test method, the Commission seeks 
comment on a proposal to replace the existing FTC cigarette test method 
with a system that would provide information on the tar, nicotine, and 
carbon monoxide yields obtained under two different smoking conditions. 
As with the current system, these ratings would not be intended to 
convey to any individual smoker what he or she would get from any 
particular cigarette. Instead, they would be intended to convey: (1) 
That a cigarette's yield depends on how it is smoked; and (2) a range 
of yields for individual cigarettes smoked under less intensive and 
more intensive smoking conditions. In addition, the Commission intends 
to accompany the revised testing methodology with a consumer education 
campaign.
1. Proposed Testing Parameters for the New Test Method
    The Commission is proposing the following modifications to its 
cigarette testing methodology:
    (1) All current procedures for the collection, storage, and 
conditioning of cigarettes would remain in place, except that the 100 
cigarettes selected for testing would be randomly divided into two 
groups of 50 cigarettes each;
    (2) 50 cigarettes of each variety would be tested under the 
conditions called for by the current FTC test method (i.e., a 2.0 
second, 35 milliliter puff every 60 seconds);
    (3) 50 cigarettes of each variety would be tested under conditions 
identical to those currently used, except that smoking machines would 
be calibrated to take a puff of 2.0 seconds duration and 55 milliliters 
volume every 30 seconds.
    The puffing parameters used in the current test method would be 
retained as the less intensive of the two testing conditions. Retaining 
these parameters would preserve the historical continuity of the 
existing test method, and thus permit long term trends in ratings to be 
identified. Furthermore, because they reflect relatively low intensity 
smoking, at least for most of today's cigarettes,11 they 
should--when coupled with

[[Page 48160]]

additional ratings reflecting testing under more intensive smoking 
conditions--provide consumers meaningful information about the 
potential variability of their own tar and nicotine exposure.
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    \11\ The Surgeon General's 1988 report reviewed 33 smoking 
studies, determined the average puffing parameters observed in each 
study and then determined the medians of those averages: a 1.8 
second, 43 milliliter puff every 28 seconds. U.S. Dept. of Health 
and Human Services, The Health Consequences of Smoking: Nicotine 
Addiction 156-57 (1988). The average puff volume seen in those 
surveys ranged from 21 milliliters to 66 milliliters; the average 
interpuff interval ranged from 18 to 64 seconds. See also NCI 
Monograph at 154 (Table 1).
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    The Commission and its staff considered whether the smoking 
conditions that would be used to generate the ratings at the upper end 
of the range should reflect the median puffing parameters identified in 
the Surgeon General's 1988 report. The Commission is proposing, 
however, that insofar as its goal is to provide meaningful information 
about the ``yields most smokers should expect,'' (see NCI Monograph at 
vii), the upper tier ratings should be determined using puffing 
parameters substantially more intensive than the ``average'' smoking 
conditions identified by the Surgeon General; a revised cigarette test 
method that had as its upper endpoint ratings produced by using the 
parameters identified in the Surgeon General's report would be skewed 
too low.
    At the same time, the Commission does not believe the upper tier of 
its proposed two-tier test method needs to incorporate puffing 
conditions designed to produced the maximum yield possible from 
individual cigarettes, in order to inform consumers about the 
importance of their own smoking behavior in influencing what they get 
from their cigarettes. Even if some smokers might take even deeper and 
more frequent puffs than those reflected in the Commission's proposed 
upper tier smoking conditions (i.e., a 2 second, 55 milliliter puff 
every 30 seconds), the dual ratings produced by the revised test method 
will still effectively communicate the impact of a smoker's own 
behavior in determining what he or she gets from any given cigarette.
    The primary objective of the proposed parameters is to provide 
smokers with a strong message that the amount of tar and nicotine they 
get from a particular cigarette is not fixed, but rather can vary 
greatly according to the way they smoke. Coupled with an appropriate 
legend in advertising and public education, the new system is intended 
to alert smokers to the phenomenon of compensatory smoking and to 
reinforce the message that smoking even the lowest rated cigarettes 
poses a significant health risk.
2. Communication of Ratings Through Advertising
    The Commission is also seeking comment on ways to improve the 
communication to consumers of tar and nicotine ratings, as well as the 
importance of individual smoking behavior. The Commission is also 
publishing two alternative disclosures for cigarette advertising (see 
Attachments A and B). Each would set out the ratings produced by the 
Commission's proposed new test method; the disclosures differ in the 
additional information they provide consumers about the importance of 
their own smoking behavior.12 The Commission seeks comment 
on the merits of these two alternative disclosures, as well as comment 
on any other statements that commenters might deem appropriate for 
communication of this information.
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    \12\ The Commission is focusing at this time primarily on the 
contents of the disclosure, and not specifically on such questions 
as what types of advertising it should be included in and what size 
it should be in those advertising media.
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3. Carbon Monoxide Ratings
    The proposed disclosures do not include carbon monoxide ratings. 
The carbon monoxide ratings produced by the revised test method would 
continue to be published in the Commission's tar and nicotine report, 
however, and would be included in smoker education efforts. The 
Commission solicits comment on whether tar and nicotine ratings can 
serve as proxies for carbon monoxide ratings.
4. Use of ``Multipliers'' To Generate the Upper-Tier Ratings
    An alternative to actual cigarette testing under the upper-tier 
parameters would be to approximate the ratings that would be produced 
under those new conditions by use of mathematical models or 
``multipliers.'' The four largest cigarette manufacturers (Philip 
Morris Incorporated, R.J. Reynolds Tobacco Company, Brown & Williamson 
Tobacco Corporation, and Lorillard Tobacco Company) have done 
exploratory testing of a number of cigarette varieties using the 
Commission's proposed upper-tier smoking parameters, have plotted the 
resulting tar, nicotine, and carbon monoxide yields against the yields 
obtained for the same cigarettes using the current FTC method, and have 
computed quadratic equations that they believe define the resulting 
curves. A report summarizing this work is being placed on the public 
record.13
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    \13\ The report is entitled An Experiment to Determine the 
General Relationship Between Cigarette Smoke Yields using an 
Alternative Puffing Regimen (55/30/2) and the Standard FTC Method 
(June 23, 1997).
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    Based on its review of the report, the Commission believes that the 
equations proposed by the companies produce results that closely 
approximate the results of actually testing cigarettes under the new 
upper-tier parameters. Accordingly, the Commission proposes that the 
companies be permitted to use these equations to calculate the tar, 
nicotine, and carbon monoxide yields that otherwise would be obtained 
by testing under the new method. The Commission solicits comment on 
this issue.
5. Alternative Approaches That Were Considered
    Under the Commission's proposed test method, all cigarettes are 
tested at the same puff intensities, even though smokers of lower rated 
cigarettes tend to smoke more intensively than smokers of higher rated 
brands and may engage in other behavior, such as filter vent blocking, 
that increases tar and nicotine yields. The Commission considered 
incorporating compensatory smoking behavior into its proposed protocol 
for the upper-tier by varying the puff parameters according to the type 
of cigarette being tested. Such a plan would use higher puffing 
parameters for lower tar cigarettes and lower puffing parameters for 
higher tar cigarettes. As a result, rating ranges would be 
proportionally larger for lower tar cigarettes, reflecting the effect 
of compensatory smoking. The Commission decided not to propose this 
approach at the present time.14 Existing research on smoking 
behavior may not be sufficiently detailed to provide an adequate basis 
for specifying different puff parameters for different groups of 
cigarettes. In addition, using different puff parameters for different 
groups of cigarettes could artificially distort the rankings of brands 
near the dividing line between those groups.15
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    \14\ The Commission also considered using the possibility of 
using a mathematical equation based on the pattern and magnitude of 
compensatory smoking behavior to approximate the effect of 
compensatory smoking on tar and nicotine yields.
    \15\ For example, if brands are assigned to different upper-tier 
puff parameters based on their ratings under the current test 
method, a brand just below the dividing line would be tested under 
more intensive upper-tier parameters than a brand just above that 
line. Use of the more intensive parameters could boost the upper-
tier ratings of the first brand substantially higher than those of 
the second brand (even though their ratings under the current test 
method are nearly the same).
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    The Commission also considered including some degree of ventilation 
hole blocking in its new, more intensive smoking conditions, but 
decided not to do so at this time.16 Instead, the

[[Page 48161]]

Commission intends to implement a consumer education program to inform 
smokers of the presence and function of aeration holes, the importance 
of not blocking them, and the magnitude of the effect that blocking 
them can have on exposure to harmful smoke constituents.17
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    \16\ Aeration holes in the filters of many brands reduce their 
ratings for tar, nicotine, and carbon monoxide by diluting the smoke 
with air before it reaches the smoking machine. Blocking these holes 
(which can be invisible) prevents dilution, and can greatly increase 
the yields of those smoke constituents. Research suggests that a 
significant number of smokers of ventilated ``low tar'' and ``ultra 
low tar'' cigarettes block some aeration holes some of the time.
    \17\ Research also shows that many smokers are unaware either of 
the existence of the vents or of the fact that vent blocking 
increases tar yield. See Kozlowski, Smokers are Unaware of the 
Filter Vents Now on Most Cigarettes: Results of a National Survey, 
Tobacco Control (forthcoming 1997). Thus, consumer education could 
also address this lack of knowledge.
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    Finally, the Commission considered keeping the current unitary 
rating system and adding disclosures warning smokers that the amount of 
tar and nicotine they get will vary depending on how a cigarette is 
smoked. This plan has the advantage of avoiding the costs and 
complexities involved in moving to a two-tier system. It would 
emphasize the artificial nature of the smoking machine measurements and 
the fact that ratings produced by machines do not indicate what smokers 
actually get from their cigarettes. The advertising disclosure, along 
with appropriate education efforts, could potentially inform smokers 
about compensation and ways to avoid it. The Commission believes, 
however, that unitary ratings will be less effective than a range of 
ratings in communicating to smokers the variability in potential smoke 
ingestion.
    The Commission is seeking comment on the desirability and 
feasibility of these alternative approaches to revising the test 
method.
6. The Industry's Recent Agreement With the State Attorneys General
    In June 1997, a proposed agreement between the four largest U.S. 
cigarette manufacturers and the Attorneys General of forty states was 
announced. The agreement contemplates that if Congress passes and the 
President signs legislation reflecting the terms of the agreement, 
responsibility for cigarette testing will be transferred from the 
Commission to the Food and Drug Administration (``FDA''). If FDA 
ultimately does receive the statutory authorization contemplated in the 
agreement, the agency would need time to review this area and 
promulgate rules setting forth its test method. In the interim, the 
Commission believes that it is important to improve the existing 
method, and that, in the confines of a voluntary system, the actions 
proposed in this notice are responsive to many of the concerns about 
the limitations of that method. The cigarette manufacturers' use of an 
improved advertising disclosure and accompanying consumer education 
efforts should advance consumer understanding about the important issue 
of compensatory smoking. Moreover, experience under the revised system 
will provide a basis for evaluating possible future changes to the 
system.
7. Conclusion
    The Commission believes that the proposed changes can be 
implemented quickly by the industry within the existing voluntary 
system significantly in advance of other possible approaches, and these 
changes address many of the problems identified in the NCI Monograph.
    Whatever changes are adopted, the Commission intends to review its 
test method every five years to assess the operation of the system and 
determine whether further changes to that method and/or the disclosure 
format are appropriate. The Commission encourages research that would 
provide additional data in all of the areas addressed by these 
revisions.

E. Request for Comments and Responses to Specific Questions

    The Commission is seeking comment on the revisions to its current 
testing methodology proposed above. The Commission is also seeking 
comments on the following specific questions and on any other issues 
relevant to the potential modification of the testing methodology:
1. The Proposed New Testing Methodology
    a. What effect, if any, are the dual ratings that would be provided 
by the Commission's proposed two-tier test method likely to have on 
consumers' purchases of cigarettes and/or their smoking behavior? Will 
this information affect smoking intensity, brand choice, and/or the 
decision whether to quit smoking, and if so, how?
    b. If the proposal for testing all cigarettes under the same two 
sets of parameters is adopted, and if the parameters incorporated in 
the Commission's test method are intended to produce yields covering 
the range likely to be experienced by most smokers, are the proposed 
parameters appropriate? Why or why not? If not, what parameters would 
be more appropriate and why?
    c. Should the butt length specified in the current FTC test 
method--that cigarettes be smoked to a length of 23 millimeters or to 3 
millimeters beyond the filter and overwrap, whichever is longer--be 
changed? Is there evidence that smokers smoke more than 3 millimeters 
beyond the end of the overwrap? If so, what is the effect of that 
behavior in terms of the number of puffs they get from their cigarette?
    d. What effect, if any, would reducing the sample size from 100 to 
50 cigarettes, as proposed, have on both the reliability and the 
replicability of the machine yield estimates? If there is an effect on 
reliability, does the fact that consumers would be given dual ratings, 
rather than a unitary rating, lessen the importance of that reduction?
    e. Can the machines presently used to smoke cigarettes pursuant to 
the FTC test method operate under the parameters in the Commission's 
proposed new protocol? If not, could they be modified to operate under 
those parameters or would new machines have to be purchased? What 
testing would be necessary to ensure the validity of the proposed 
modifications to the test method--that is, to ensure that the revised 
protocol will produce highly reliable and replicable results? How long 
would such validation take?
    f. Could the ratings for the upper tier of the revised test method 
be obtained from mathematical equations or ``multipliers''? Why or why 
not? Would the continuing validity of the equations have to be 
reconfirmed periodically through actual machine smoking and, if so, how 
often?
    g. Should the cigarette manufacturers be permitted to use the 
mathematical equations they submitted to the Commission to calculate 
the ratings that would be produced by testing under the proposed upper-
tier parameters? Why or why not? If the industry is permitted to use 
such mathematical equations, should it continue to use 100 cigarettes, 
rather than 50, to determine the lower-tier ratings? Why or why not?
    h. How much would the proposed two-tier testing system cost the 
cigarette industry to implement as compared to the current system? How 
much would the proposed two-tier testing system cost the cigarette 
industry to implement if 100 cigarettes, rather than 50, were smoked 
under each test condition? How much would the proposed revisions to the 
test method cost the industry to implement if mathematical equations 
were used to generate the upper-tier ratings?
2. Alternative Options for Revising the Test Method
    a. Should the upper tier of the two-tier test method reflect the 
tendencies of smokers of lower rated and heavily aerated (i.e., vented) 
cigarettes to smoke more intensively (by taking more puffs, bigger 
puffs, etc.) or to block some or all

[[Page 48162]]

of the ventilation holes while smoking? If so, how should the test 
protocol be modified in order to obtain tar and nicotine ratings that 
would accurately reflect the effect of these and other forms of 
compensatory smoking behavior? Would ratings generated by such a test 
protocol affect smoking intensity, brand choice, and/or the decision 
whether to quit smoking, and if so, how?
    b. Could compensatory smoking behavior be incorporated into the 
test by using different test parameters for different groups of 
cigarettes (i.e. higher test parameters for lower rated cigarettes and 
lower test parameters for higher rated cigarettes)? If so, how many 
different groups of cigarettes should there be, and what parameters 
should be applied to each group? Where should the line(s) separating 
the groups be drawn? Would using different sets of parameters 
overemphasize differences in yields between brands on either side of 
the dividing line(s)? Would it cause cigarettes on either side of the 
dividing line(s) to ``switch rankings'' with respect to their upper 
tier ratings? If so, do these potential outcomes make the use of 
different parameters for different cigarettes undesirable?
    c. Could the effect of compensatory smoking behavior be 
incorporated into the test by blocking some or all of the aeration 
vents during testing? What does the available evidence demonstrate 
about the prevalence of vent blocking and about the percentage of vents 
that are blocked by those smokers who do engage in vent blocking? What 
effect, if any, does vent blocking have on smokers' puff frequency, 
puff volume, and puff duration? If vent blocking were to be included in 
the upper tier of testing, how should that blocking be accomplished? If 
vent blocking were used to generate upper-tier tar and nicotine yields, 
would this lead cigarette companies to switch from filter aeration to 
some other method of creating lower yield cigarettes? If so, what would 
be the effect on the relevance of the upper-tier yields?
    d. Could the effects of compensatory smoking behavior be 
incorporated into mathematical equations or multipliers that could be 
applied to the current FTC ratings to calculate ``compensation-
adjusted'' ratings? Do existing studies of smoking behavior provide a 
sufficient basis to create an equation or set of multipliers that could 
be used to approximate the compensation effect? How closely could 
equations approximate the compensation effect? What degree of accuracy 
is necessary? Would an approximation be acceptable? Can existing 
studies measuring nicotine intake of smokers be used to make inferences 
about tar intake, or is the effect of compensation behavior likely to 
be different for tar and nicotine?
3. Advertising Disclosures and Consumer Education
    a. Is the language of either of the proposed disclosures for 
cigarette advertising (Attachments A and B) likely to communicate 
effectively to consumers that their tar and nicotine intake from a 
cigarette will vary depending on how they smoke it?
    b. Are the proposed disclosures likely to be more effective in 
conveying useful information to consumers than current advertising 
disclosures? What changes, if any, should be made to either the content 
(including the specific words used) or the layout of either of the 
disclosures? Are there other disclosure formats that would be more 
effective?
    c. What effect, if any, is either of the proposed disclosures 
likely to have on consumers' purchases of cigarettes and/or their 
smoking behavior? Is there reason to believe this information will 
affect smoking intensity, brand choice, and/or the decision whether to 
quit smoking, and if so, how?
    d. The proposed disclosures do not contain information regarding 
carbon monoxide ratings. Should information regarding carbon monoxide 
ratings be included in any disclosure format that is adopted? Why or 
why not? If such information is provided, how should it be done? How 
closely do carbon monoxide ratings obtained in smoking machine tests 
correlate with tar and nicotine ratings?
    e. Should the disclosures include information concerning the ratio 
of the cigarette's tar and nicotine ratings? Would these ratios provide 
useful information to smokers?
    f. Would it be necessary to require that the disclosures be printed 
in black text on a white background, or would it be sufficient to 
retain the standard embodied in the cigarette manufacturers' 1970 
agreement--that is, that the disclosure be clear and prominent?
    g. What kinds of disclosures and public education efforts should be 
undertaken to inform smokers about compensatory smoking? What evidence 
exists on the likelihood that smokers will change their behavior when 
advised of compensatory smoking techniques and how to avoid them? Can 
graphic techniques used by researchers to measure compensatory smoking 
(e.g., color and stain pattern matching) be used by consumers to 
evaluate the extent of their own compensatory smoking?
    h. What kinds of consumer education messages should be created to 
inform smokers of the presence of filter vents and of the importance of 
not blocking them with their fingers or lips?
    i. What other kinds of consumer education messages should accompany 
the Commission's revision of the cigarette test method?
    j. How would the proposed new testing method and each of the 
various alternative methods that were considered likely complement or 
detract from possible consumer education initiatives?
4. Other Possible Policy Options
    a. Rather than move to a two-tier test method, would it be 
preferable to continue to test cigarettes under a single protocol and 
use consumer education and an advertising disclosure to inform 
consumers what the ratings do and do not represent, and that what 
smokers get from any particular cigarette depends in large part on how 
they smoke it? If so, should cigarettes continue to be tested under a 
protocol that uses a 2 second, 35 milliliter puff every minute, or 
should different smoking parameters be used? What form should such 
consumer education take (e.g., informational materials at the point of 
purchase) and what should it say?
    b. Rather than move to a two-tier test method, would it be 
preferable to drop all FTC approval of the tar and nicotine testing 
system? Are all potential ratings so inherently flawed and misleading, 
and the possibilities for improving the system so unlikely to succeed, 
that use of any numerical tar and nicotine ratings should be ended? 
Would such a change affect smoking intensity, brand choice, and/or the 
decision whether to quit smoking, and if so, how?
    c. Should the cigarette test method attempt to measure or otherwise 
account for the bioavailability of the nicotine in different 
cigarettes? If so, how should it do so? Is the alkalinity of the 
nicotine a surrogate for bioavailability? Is there a mathematical model 
by which bioavailability can be computed from nicotine yield, 
alkalinity, and other information?
    d. If the effect of compensatory smoking behavior is not 
incorporated in the tar and nicotine ratings, should a disclosure 
warning smokers about compensatory smoking behavior be required in all 
ads? Would such a disclosure likely be effective in reinforcing the 
consumer education efforts?
5. Other Issues
    a. What available evidence exists concerning how consumers view

[[Page 48163]]

cigarettes with relatively low tar and nicotine ratings and their 
perception of the relative risks of smoking such cigarettes rather than 
full flavor cigarettes?
    b. Do the biological markers used to estimate nicotine ingestion in 
human smoking studies provide adequate estimates of likely tar 
ingestion? If not, what other evidence can be used to predict tar 
intake?
    c. Earlier this year, the National Institutes of Health issued 
Smoking and Tobacco Control Monograph 8--Changes in Cigarette-Related 
Disease and Their Implication for Prevention and Control. The 
Monograph, which presents the results of three large new 
epidemiological studies and additional follow-up data for two older 
studies from the 1950's, notes (pp. ix-x) that:

    When observations from the more contemporary studies are 
compared with those from the 1950's, one important but disturbing 
conclusion is apparent--mortality risks among continuing smokers, 
both males and females, have increased.

    What effect, if any, do the findings reported in this Monograph 
have on the Ad Hoc Committee's conclusion that the smoking of 
``cigarettes with lower machine-measured yields has a small effect in 
reducing the risk of cancer caused by smoking''?

II. Cigarette Descriptors

    Cigarette manufacturers use a number of descriptive terms (such as 
``low tar,'' ``light,'' ``medium,'' ``extra light,'' ``ultra light,'' 
``ultra low,'' and ``ultima'') in advertising and labeling information 
about their cigarettes. The Ad Hoc Committee of the President's Cancer 
Panel concluded that ``[b]rand names and brand classifications such as 
``light'' and ``ultra light'' represent health claims and should be 
regulated and accompanied, in fair balance, with an appropriate 
disclaimer.''
    There are no official definitions for these terms but they appear 
to be used by the industry to reflect ranges of FTC tar ratings. 
Generally, the term ``low tar'' is used to mean tar ratings of 7 to 15 
milligrams, and the term ``ultra low tar'' is used to mean tar ratings 
of 6 milligrams or less. The Commission is beginning the process of 
examining these questions by seeking comment on the following issues:
    1. Is there a need for official guidance with respect to the terms 
used in marketing lower rated cigarettes? If yes, why? If no, why not?
    2. What data, evidence or other relevant information on consumer 
interpretation and understanding of terms such as ``ultra low tar,'' 
``ultra light,'' ``low tar,'' ``light,'' ``medium,'' ``extra light'' 
and ``ultima,'' as used in the context of cigarettes exists? Do 
consumers believe they will get significantly less tar from cigarettes 
described as ``light'' or ``low tar'' than from regular or full flavor 
cigarettes, and do they believe they will get significantly less tar 
from cigarettes described as ``ultra low tar'' or ``ultra light'' than 
from ``light'' or ``low tar'' cigarettes? Do the descriptors convey 
implied health claims?
    3. Do consumers use descriptors, rather than the FTC tar and 
nicotine ratings, as their primary source of information about the tar 
and nicotine yields of different cigarette brands? What data or 
evidence examines this question? If consumers use descriptors as their 
primary source of information about tar and nicotine yields, what 
implications does this have for the proposed revisions to the test 
method and the advertising disclosure?

    By direction of the Commission.
Donald S. Clark,
Secretary.

Attachment A

------------------------------------------------------------------------
                                                                        
-------------------------------------------------------------------------
There's no such thing as a safe smoke.                                  
Even cigarettes with low ratings can give you high amounts of tar and   
 nicotine. It depends on how you smoke.                                 
2 mg.-6 mg. tar, 0.2 mg,-0.6 mg nicotine per cigarette by FTC method.   
------------------------------------------------------------------------

Attachment B

2 mg.-6 mg. tar, 0.2 mg. -0.6 mg. nicotine per cigarette by FTC 
method

    How much tar and nicotine you get from a cigarette depends on 
how intensely you smoke it.

[FR Doc. 97-24246 Filed 9-11-97; 8:45 am]
BILLING CODE 6750-01-P