Cigarette Testing; Request for Public Comment

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