48158 Federal Register / Vol. 62, No. 177 / Friday, September 12, 1997 / Notices

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.

2 32 FR 11178 (Aug. 1, 1967).

3Testing for carbon monoxide was added to the

protocol in 1980.

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.

6FTC 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).

8The 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

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.

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 51⁄4 or a 31⁄2 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

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

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

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
Federal Register / Vol. 62, No. 177 / Friday, September 12, 1997 / Notices 48159

Smoking: The Changing Cigarette at 1 (1981)

(quoting 1966 Public Health Service statement).

9The 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’’).

10NCI Monograph at vi–viii.

11The 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).

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:

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

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
48160 Federal Register / Vol. 62, No. 177 / Friday, September 12, 1997 / Notices

12The 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.

13The 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).

14The 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.

15For 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).

16Aeration 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

additional ratings reflecting testing

under more intensive smoking

conditions—provide consumers

meaningful information about the

potential variability of their own tar and

nicotine exposure.

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.

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

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

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
Federal Register / Vol. 62, No. 177 / Friday, September 12, 1997 / Notices 48161

‘‘ultra low tar’’ cigarettes block some aeration holes

some of the time.

17Research 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.

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

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 lowertier 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 twotier 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
48162 Federal Register / Vol. 62, No. 177 / Friday, September 12, 1997 / Notices

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 ‘‘compensationadjusted’’ 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
Federal Register / Vol. 62, No. 177 / Friday, September 12, 1997 / Notices 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