[Federal Register Volume 73, Number 135 (Monday, July 14, 2008)]
[Notices]
[Pages 40350-40352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16006]


=======================================================================
-----------------------------------------------------------------------

FEDERAL TRADE COMMISSION


Proposal to Rescind FTC Guidance Concerning the Current Cigarette 
Test Method

AGENCY: Federal Trade Commission

ACTION: Notice

-----------------------------------------------------------------------

SUMMARY: The Federal Trade Commission (``FTC'' or ``Commission'') is 
proposing to rescind its guidance that it is generally not a violation 
of the FTC Act to make factual statements of the tar and nicotine 
yields of cigarettes when statements of such yields are supported by 
testing conducted pursuant to the Cambridge Filter Method, also 
frequently referred to as ``the FTC Test Method.'' If it withdraws this 
guidance, advertisers should not use terms such as ``per FTC Method'' 
or other phrases that state or imply FTC endorsement or approval of the 
Cambridge Filter Method or other machine-based test methods. The 
Commission seeks public comments on its proposal.

DATES: Comments must be submitted on or before August 12, 2008.

ADDRESSES: Interested parties are invited to submit comments. Comments 
should refer to ``Cigarette Test Method, [P944509]'' to facilitate the 
organization of comments. A comment filed in paper form should include 
this reference both in the text and on the envelope, and should be 
mailed or delivered, with two complete copies, to the following 
address: Federal Trade Commission, Office of the Secretary, Room H-135 
(Annex L), 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. 
Because paper mail in the Washington area and at the Commission is 
subject to delay, please consider submitting your comments in 
electronic form, as described below. However, if the comment contains 
any material for which confidential treatment is requested, it must be 
filed in paper form, and the first page of the document must be clearly 
labeled ``Confidential.''\1\
---------------------------------------------------------------------------

    \1\ Commission Rule 4.2(d), 16 CFR 4.2(d). The comment must be 
accompanied by an explicit request for confidential treatment, 
including the factual and legal basis for the request, and must 
identify the specific portions of the comment to be withheld from 
the public record. The request will be granted or denied by the 
Commission's General Counsel, consistent with applicable law and the 
public interest. See Commission Rule 4.9(c), 16 CFR 4.9(c).
---------------------------------------------------------------------------

    Comments filed in electronic form should be submitted by following 
the instructions on the web-based form at (https://secure.commentworks.com/ftc-CigaretteTestMethod). To ensure that the 
Commission considers an electronic comment, you must file it on the 
web-based form at the (https://secure.commentworks.com/ftc-CigaretteTestMethod) weblink. If this Notice appears at 
www.regulations.gov, you may also file an electronic comment through 
that web site. The Commission will consider all comments that 
regulations.gov forwards to it.

[[Page 40351]]

    The FTC Act and other laws the Commission administers permit the 
collection of public comments to consider and use in this proceeding as 
appropriate. All timely and responsive public comments, whether filed 
in paper or electronic form, will be considered by the Commission, and 
will be available to the public on the FTC web site, to the extent 
practicable, at www.ftc.gov. As a matter of discretion, the FTC makes 
every effort to remove home contact information for individuals from 
the public comments it receives before placing those comments on the 
FTC web site. More information, including routine uses permitted by the 
Privacy Act, may be found in the FTC's privacy policy at (http://www.ftc.gov/ftc/privacy/htm).

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
should be addressed to Rosemary Rosso, Senior Attorney, Division of 
Advertising Practices, Bureau of Consumer Protection, Federal Trade 
Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580, 
(202) 326-2174.

SUPPLEMENTARY INFORMATION: Cigarette yields for tar, nicotine, and 
carbon monoxide are currently measured by the Cambridge Filter Method, 
which has been commonly referred to as ``the FTC Method.'' For some 
time, the Commission has been concerned that the machine-measured 
yields determined by the Cambridge Filter Method may be misleading to 
individual consumers who rely on the yields as indicators of the amount 
of tar, nicotine, and carbon monoxide they actually will get from 
smoking a particular cigarette. In fact, the current yields tend to be 
relatively poor indicators of tar, nicotine, and carbon monoxide 
exposure, and do not provide a good basis for comparison among 
cigarettes. Accordingly, the Commission proposes to withdraw its 
guidance, announced in 1966, indicating that factual statements of tar 
and nicotine yields based on the Cambridge Filter Method generally will 
not violate the FTC Act. If the Commission withdraws this guidance, 
advertisers should not use terms such as ``per FTC Method'' or other 
phrases that state or imply FTC endorsement or approval of the 
Cambridge Filter Method or other machine-based test methods. The 
Commission invites public comment on its proposal.

I. BACKGROUND

    On March 25, 1966, the Commission informed the major cigarette 
manufacturers that factual statements of the tar and nicotine content 
of the mainstream smoke of cigarettes would not be in violation of 
legal provisions administered by the FTC:
 so long as: (1) no collateral representations (other than factual 
statements of tar and nicotine content of cigarettes offered for sale 
to the public) are made, expressly or by implication, as to reduction 
or elimination of health hazards, and (2) the statement of tar and 
nicotine content is supported by adequate records of tests conducted in 
accordance with the Cambridge Filter Method.\2\
---------------------------------------------------------------------------

    \2\ News Release of the Federal Trade Commission (Mar. 25, 1966) 
(reciting the text of identical letters sent to the major cigarette 
manufacturers and the Administrator of The Cigarette Advertising 
Code, Inc.). The Cambridge Filter Method determines the relative 
yields of individual cigarettes by ``smoking'' them in a 
standardized fashion, according to a pre-determined protocol, on a 
machine. The machine is calibrated to take one puff of 2-seconds 
duration and 35 ml. volume every minute, and to smoke the cigarettes 
to a specified length.
---------------------------------------------------------------------------

    Importantly, the 1966 guidance only addresses simple factual 
statements of tar and nicotine yields. It does not apply to other 
conduct or express or implied representations, even if they concern tar 
and nicotine yields. Thus, deceptive claims about tar and nicotine 
yields or health risks are still subject to the full force of the 
Commission's jurisdiction. See, e.g., FTC v. Brown & Williamson Tobacco 
Corp., 778 F. 2d 35 (D.C. Cir. 1985); American Tobacco Co., 119 F.T.C. 
3 (1995). Moreover, the Commission's 1966 guidance does not require 
companies to state the tar and nicotine yields of their cigarettes in 
their advertisements or on product labels. Rather, it sets forth the 
type of substantiation the Commission would deem adequate to support 
statements of tar and nicotine yields if cigarette companies choose to 
make such statements.
    From the outset, cigarette testing under the Cambridge Filter 
Method was intended to produce uniform, standardized data about the tar 
and nicotine yields of mainstream cigarette smoke, not to replicate 
actual human smoking. Because no known test could accurately replicate 
human smoking, the FTC believed that the most important objective was 
to ensure that cigarette companies could present tar and nicotine 
information to the public based on a standardized method that would 
allow comparisons among cigarettes. In 1966, most public health 
officials believed that reducing the amount of ``tar'' in a cigarette 
could reduce a smoker's risk of lung cancer. Therefore, it was thought 
that giving consumers uniform and standardized information about the 
tar and nicotine yields of cigarettes would help smokers make informed 
decisions about the cigarettes they smoked.\3\
---------------------------------------------------------------------------

    \3\ When the test method was adopted, the public health 
community believed that ``[t]he preponderance of scientific 
information 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 1(1981) (quoting a 1966 Public 
Health Service statement).
---------------------------------------------------------------------------

    During the 40 years since the Commission announced this guidance, 
machine-measured tar and nicotine yields of cigarettes have decreased 
dramatically. In 1968, for example, only 2% of all cigarettes had 
machine-measured yields of 15 mg or less. Today, over 85% of all 
cigarettes sold have machine-measured yields of 15 mg or less.
    Despite these dramatic decreases in machine-measured yields, the 
Commission has been concerned for some time that the current test 
method may be misleading to individual consumers who rely on the 
ratings it produces as indicators of the amount of tar and nicotine 
they actually will get from their cigarettes, and who use this 
information as a basis for comparison when choosing which cigarettes 
they smoke. In fact, the current yields tend to be relatively poor 
predictors of tar and nicotine exposure. This is primarily due to 
smoker compensation--i.e., the tendency of smokers of lower-rated 
cigarettes to take bigger, deeper, or more frequent puffs, or to 
otherwise alter their smoking behavior in order to obtain the dosage of 
nicotine they need. Such compensatory behavior in the way people smoke 
and changes in cigarette design that facilitate compensation can have 
significant effects on the amount of tar, nicotine, and carbon monoxide 
one gets from any particular cigarette.
    Concerns about the machine-based Cambridge Filter Method became a 
substantial issue in the 1990s because of changes in modern cigarette 
design and due to a better understanding of the nature and effects of 
compensatory smoking behavior.\4\

[[Page 40352]]

    Today, the consensus of the federal health agencies and the 
scientific community is that machine-based measurements of tar and 
nicotine yields using the Cambridge Filter Method ``do not offer 
smokers meaningful information on the amount of tar and nicotine they 
will receive from a cigarette, or on the relative amounts of tar and 
nicotine exposure they are likely to receive from smoking different 
brands of cigarettes.''\5\
---------------------------------------------------------------------------

    \4\ To address these concerns, in 1994, the Commission, along 
with Congressman Henry Waxman, asked the National Cancer Institute 
(``NCI'') to convene a consensus conference to address cigarette 
testing issues. That conference took place in December 1994. 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, National Institutes 
of Health, National Cancer Institute (1996).
    In 1997, the Commission published a Federal Register Notice 
proposing certain changes to the test method in accordance with 
recommendations from the NCI consensus conference. 42 Fed. Reg. 
48,158 (Sept. 12, 1997). In response, the cigarette companies argued 
in favor of retaining the existing test method. Public health 
agencies asked the Commission to postpone its proposed modifications 
until a broader review of unresolved scientific issues surrounding 
the system could be addressed.
    In 1998, the Commission responded to the public health agencies' 
concerns by formally requesting that the Department of Health and 
Human Services (``DHHS'') conduct a review of the FTC's cigarette 
test method. Letter from Donald S. Clark, Secretary, Federal Trade 
Commission to the Honorable Donna E. Shalala, Secretary, Department 
of Health and Human Services (Nov. 19, 1998). In particular, the 
Commission asked the DHHS to provide recommendations as to whether 
the testing system should be continued, and, if it should be 
continued, what specific changes should be made in order to correct 
the limitations previously identified by the NCI and other public 
health officials.
    The DHHS provided its initial response to the FTC in an NCI 
Report concerning the public health effects of low tar cigarettes. 
Smoking and Tobacco Control Monograph 13: Risks Associated with 
Smoking Cigarettes with Low Machine-Measured Yields of Tar and 
Nicotine, National Institutes of Health, National Cancer Institute 
(2001) (``Monograph 13''). The national panel of scientific experts 
assembled for the review concluded that the existing scientific 
evidence, including patterns of mortality from smoking-caused 
diseases, does not indicate a benefit to public health from changes 
in cigarette design and manufacturing over the past 50 years. 
Monograph 13 at 10. Monograph 13 also concluded that measurements of 
tar and nicotine as measured by the Cambridge Filter Method do not 
offer meaningful information to consumers. Id.
    When it announced the release of Monograph 13, the NCI noted the 
FTC's previous request, and indicated that it would work with its 
sister science-based agencies at DHHS to determine what changes 
needed to be made to the testing method. National Cancer Institute, 
``Low-Tar Cigarettes: Evidence Does Not Indicate a Benefit to Public 
Health,'' News from the NCI (Nov. 27, 2001). The FTC understands 
that representatives from agencies within DHHS are continuing to 
look into these issues.
    In light of its concerns, the Commission for more than a decade 
has recommended that Congress grant authority over cigarette testing 
to one of the federal government's science-based public health 
agencies. See, e.g., Prepared Statement of the Federal Trade 
Commission Before the Committee on Energy, Commerce, and 
Transportation, United States Senate (Nov. 13, 2007).
    \5\ Testimony of Cathy Backinger, Ph.D., Acting Chief, Tobacco 
Control Research Branch, National Cancer Institute, presented before 
the Committee on Science, Commerce and Transportation, U.S. Senate 
(Nov. 13, 2007). See also Testimony of Jonathan M. Samet, M.D., 
M.S., Professor and Chair, Dept. of Epidemiology, Johns Hopkins 
Bloomberg School of Public Health, presented before the Committee on 
Science, Commerce and Transportation, U.S. Senate (Nov. 13, 2007); 
Smoking and Tobacco Control Monograph 13: Risks Associated with 
Smoking Cigarettes with Low Machine-Measured Yields of Tar and 
Nicotine, National Institutes of Health, National Cancer Institute 
(2001) .
---------------------------------------------------------------------------

II. PROPOSAL TO RESCIND COMMISSION GUIDANCE CONCERNING FACTUAL 
STATEMENTS OF TAR AND NICOTINE YIELDS

    The Commission proposes to rescind its guidance that generally 
permits factual statements about the tar and nicotine yields of a 
cigarette when such statements are supported by the Cambridge Filter 
Method.\6\ If it rescinds its guidance, advertisers should not use 
terms such as ``per FTC Method'' or other phrases that state or imply 
FTC endorsement or approval of the Cambridge Filter Method or other 
machine-based test methods.
---------------------------------------------------------------------------

    \6\ Cigarette manufacturers have adopted descriptive terms such 
as ``light'' and ``ultra low'' apparently based on ranges of 
machine-measured tar yields. The Commission has not defined those 
terms, nor provided guidance or authorization as to the use of 
descriptors. Because there is no Commission enforcement policy with 
respect to the use of descriptors, this proposal does not address 
the use of descriptors.
---------------------------------------------------------------------------

A. Tar and Nicotine Statements Based on Cambridge Test Method

    Given the serious limitations of the existing test method, the 
Commission's rationale for its 1966 guidance generally permitting 
factual tar and nicotine statements based on this methodology no longer 
appears valid. The Commission is concerned that statements based on the 
Cambridge Filter Method may be confusing or misleading to consumers who 
believe they will get proportionately less of the harmful substances 
from cigarette smoke by smoking relatively lower-yield cigarettes than 
from higher-yield cigarettes. Thus, the Commission proposes to rescind 
its guidance that generally permits claims based upon a single 
standardized machine-based test method -- the Cambridge Filter Method. 
Upon withdrawal of this guidance, factual statements about tar and 
nicotine yields would be evaluated the same as any other advertising or 
marketing claims subject to the Commission's jurisdiction: the 
statements could be made as long as they were truthful, non-misleading, 
and adequately substantiated.

B. Claims Stating or Implying FTC Endorsement or Approval

    Additionally, the Commission believes it should not permit claims 
that consumers are likely to interpret as FTC approval, ownership, or 
endorsement of the Cambridge Filter Method. Thus, if the Commission 
withdraws the guidance, advertisers should not use terms such as ``per 
FTC Method'' or other phrases that state or imply FTC approval, 
ownership, or endorsement of the Cambridge Filter Method or other 
machine-based test methods.

III. REQUEST FOR COMMENTS AND RESPONSES TO SPECIFIC QUESTIONS

    The Commission is seeking comment on the following specific 
questions and on any other issues relevant to the policies stated above 
in this Notice:
    1. Should the Commission rescind its guidance that generally 
permits factual statements about tar and nicotine yields when such 
statements are based on a single standardized test method--the 
Cambridge Filter Method?
    2. What effects, if any, would the Commission's proposal likely 
have on consumers' purchases of cigarettes and/or their smoking 
behavior? Will these changes be likely to affect smoking intensity, 
brand choice, and/or the decision whether to quit smoking, and if so, 
how? How else would the proposal likely affect consumers?
    By direction of the Commission.

Donald S. Clark
Secretary
[FR Doc. E8-16006 Filed 7-11-08: 8:45 am]
BILLING CODE 6750-01-S