[Federal Register Volume 73, Number 236 (Monday, December 8, 2008)]
[Notices]
[Pages 74500-74505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28969]


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

FEDERAL TRADE COMMISSION


Rescission of FTC Guidance Concerning the Cambridge Filter Method

AGENCY: Federal Trade Commission

ACTION: Notice

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

SUMMARY: The Federal Trade Commission (``FTC'' or ``Commission'') has 
rescinded its 1966 guidance providing that it is generally not a 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 Method.'' In addition, 
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.

DATES: Except as specified in this notice, the Commission's rescission 
of the guidance is effective on November 26, 2008.

ADDRESSES: Requests for copies of this notice should be sent to the 
Consumer Response Center, Room 130, Federal Trade Commission, 600 
Pennsylvania Avenue, NW, Washington, DC 20580. The notice is also 
available on the Internet at the Commission's web site, http://www.ftc.gov.

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, NW, Washington, DC 20580, (202) 
326-2174.

SUPPLEMENTARY INFORMATION: Cigarette yields for tar, nicotine, and 
carbon monoxide are typically measured by the Cambridge Filter Method, 
which commonly has been referred to as ``the FTC Method.'' On July 14, 
2008, the Commission published a Federal Register notice seeking 
comment on a proposal to rescind guidance the Commission issued in 
1966, which stated that it generally is 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. 73 Fed. Reg. 40350 (July 14, 
2008). The Notice sought comment concerning the Commission's proposal, 
and the likely effects of rescission of the FTC guidance. On July 30, 
the Commission extended the comment

[[Page 74501]]

period until September 12, 2008. 73 Fed. Reg. 44268 (July 30, 2008).

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.\1\
---------------------------------------------------------------------------

    \1\ 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 addressed simple factual 
statements of tar and nicotine yields. It did not apply to other 
conduct or express or implied representations, even if they concerned 
tar and nicotine yields. Thus, deceptive claims about tar and nicotine 
yields or health risks continued to be 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 did not require 
companies to state the tar and nicotine yields of their cigarettes in 
their advertisements or on product labels. Rather, it set forth the 
type of substantiation the Commission would deem adequate to support 
statements of tar and nicotine yields if cigarette companies chose 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 test known at the time 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.\2\
---------------------------------------------------------------------------

    \2\ 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).
---------------------------------------------------------------------------

    Despite dramatic decreases in machine-measured tar and nicotine 
yields since then, 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, or 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.
    Concerns about the machine-based Cambridge Filter Method became a 
substantially greater 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.\3\ 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.''\4\
---------------------------------------------------------------------------

    \3\ 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). 
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.
    \4\ 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); 
Monograph 13.
---------------------------------------------------------------------------

    Given the serious limitations of the existing test method, the 
Commission published a Federal Register Notice seeking comment on a 
proposal to rescind its guidance providing that factual statements 
supported by testing conducted pursuant to the Cambridge Filter Method 
generally would not violate the FTC Act.

II. COMMENTS RECEIVED IN RESPONSE TO COMMISSION'S NOTICE

    The Commission received 36 comments in response to its Federal 
Register Notice.\5\ Of those, 27 commenters supported the proposal to 
rescind the 1966 guidance, seven comments opposed the proposal, and two 
comments neither supported nor opposed the specific proposal to rescind 
the 1966 guidance.\6\ The comments are discussed below.
---------------------------------------------------------------------------

    \5\ The comments are cited in this notice by reference to the 
name of the commenter. The comments are available on the Internet at 
the Commission's web site, http://www.ftc.gov. The comments also are 
on the public record and are available for public inspection by 
contacting the Consumer Response Center, 600 Pennsylvania Avenue, 
NW, Washington, DC 20580 from 9 a.m. to 5 p.m. Monday through 
Friday, except federal holidays.
    \6\ One of these comments, from a church organization, indicated 
the group's general concern that any tobacco use is harmful. In 
addition, an individual expressed the view that the Commission was 
complicit in deceptions by cigarette companies.

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

[[Page 74502]]

A. Comments Supporting the Proposal

    Comments supporting the Commission's proposal to rescind its 1966 
guidance came from public health and tobacco advocacy organizations, an 
international health organization, a municipal health department, 
academic and health professionals, individuals, and Members of the 
United States Senate.\7\
---------------------------------------------------------------------------

    \7\ The commenters are the American Academy of Pediatrics, the 
American Cancer Society Cancer Action Network, American Legacy 
Foundation, Dr. A. Brandt, Campaign for Tobacco Free Kids (joined by 
19 health-related organizations), Dr. G. Connolly, Dr. M. Eriksen, 
Joanie Fogel, M. Hauckq, K. Karnes, D. Kasper, P. Konigsberg, 
Konigsberg, Senator Lautenberg (joined by 15 additional Senators), 
Dr. J. Love, Dr. D. Lynch, A. Moore, NYC Department of Health and 
Hygiene, Dr. R. O'Connor, Partnership for Prevention, M. Reilly, 
Smokefree Pennsylvania, Dr. M. Thun, Dr. N. Benowitz, Dr. D. Burns, 
Dr. K. Warner, and the World Health Organization (``WHO'').
---------------------------------------------------------------------------

1. Basis for Support
    One commenter, an official at the American Cancer Society, stated 
that the guidance should be rescinded because it has not served its 
purpose of informing consumers about brands that confer less risk of 
tobacco-related harm.\8\ Several commenters indicated their support for 
the proposal because the tar and nicotine yields derived through the 
Cambridge Filter Method do not provide meaningful information about the 
relative health risks among cigarette brands.\9\ Other commenters 
stated that machine-based yields do not provide meaningful information 
to consumers about the amount of tar and nicotine actually inhaled by 
smokers or the differences in exposure they would receive when 
switching brands of cigarettes.\10\ Some of these commenters cited 
research showing that there is no meaningful difference in a smoker's 
exposure to tar and nicotine based on whether that smoker smoked 
``light'' or low tar cigarettes, or regular full-flavored 
cigarettes.\11\ Many of the commenters stated that the tar and nicotine 
yields derived from the Cambridge Filter method are misleading to 
consumers.\12\ Some commenters cited studies indicating that consumers 
mistakenly believe that lower yield cigarettes confer a reduced risk of 
harm relative to higher yield cigarettes.\13\
---------------------------------------------------------------------------

    \8\ Thun.
    \9\ E.g., Brandt, Kasper, NYC Dept. of Health.
    \10\ E.g., Campaign for Tobacco Free Kids, American Academy of 
Pediatrics, Connolly, Hackq, Benowitz, Burns, WHO.
    \11\ E.g., American Legacy Foundation, Campaign for Tobacco Free 
Kids, Connolly.
    \12\ E.g., American Legacy Foundation, Brandt, Campaign for 
Tobacco Free Kids, Connolly, Eriksen, Karnes, Lautenberg, Moore, 
O'Connor, Partnership for Prevention, Thun, Warner, WHO.
    \13\ E.g., Thun.
---------------------------------------------------------------------------

2. Likely Effects of Rescinding the 1966 Guidance
    Some of the commenters stated that rescinding the 1966 Guidance 
would help ensure that consumers are not misled and would lead to a 
better public understanding that lower yield cigarettes do not reduce 
health risks caused by smoking.\14\ Other commenters indicated that 
rescinding the guidance would facilitate smoking cessation by 
eliminating deceptive claims.\15\ One commenter stated that rescinding 
the guidance would allow consumers to make more informed choices about 
cigarettes by no longer permitting information that minimizes the 
health risks associated with smoking.\16\ Another indicated that 
rescission of the guidance was likely to have positive effects on 
smoking intensity, brand choice, and/or attempts to quit smoking.\17\ 
One organization stated that Commission withdrawal of the guidance 
would help public health organizations be more effective in their 
efforts to support smoking cessation and to prevent youth initiation of 
smoking.\18\
---------------------------------------------------------------------------

    \14\ E.g., American Legacy Foundation, Brandt, Eriksen, NYC 
Dept. of Health.
    \15\ E.g., Campaign for Tobacco Free Kids, Connolly, Fogel, 
Karnes, Kasper, Lautenberg, Love, Partnership for Prevention.
    \16\ NYC Dept. of Health.
    \17\ Love.
    \18\ Campaign for Tobacco Free Kids.
---------------------------------------------------------------------------

B. COMMENTS OPPOSING THE PROPOSAL

    The Commission received comments opposing its proposal from the 
four major domestic cigarette manufacturers, and three individuals.\19\
---------------------------------------------------------------------------

    \19\ Liggett Group LLC, Lorillard Tobacco Company, Philip Morris 
USA, R.J. Reynolds Tobacco Company, Dr. J. Nitzkin, Dr. R. Shipley, 
Dr. C. Wright.
---------------------------------------------------------------------------

1. Comments from Individuals
    One individual, affiliated with a smoking cessation program, 
indicated that the current test method provides useful information to 
consumers trying to quit smoking by allowing them to choose brands that 
have very low yields of nicotine as an initial part of the cessation 
process.\20\ The other two individuals stated that the FTC should fix 
the existing method rather than rescind its guidance.\21\ One of these 
comments added that once the test method is fixed, the FTC should amend 
its guidance to require companies to test not only tar, nicotine, and 
carbon monoxide yields, but also other identified toxins in tobacco 
smoke such as aldehydes, benzopyrenes, and tobacco-specific 
nitrosamines, and to require cigarette companies to disclose those 
yields on cigarette packages.\22\
---------------------------------------------------------------------------

    \20\ Shipley.
    \21\ Wright, Nitzkin.
    \22\ Wright.
---------------------------------------------------------------------------

2. Industry Comments
    Each of the four major domestic cigarette manufacturers stated that 
the FTC should retain the current guidance. These commenters said that 
the 1966 guidance, permitting the use of a single standardized test 
method, the Cambridge Filter method, should be retained until a 
replacement or supplemental test method is approved.\23\ These 
commenters noted that federal and international scientific authorities 
currently are exploring means for addressing the limitations of 
machine-based test methods such as the Cambridge Filter method.
---------------------------------------------------------------------------

    \23\ Liggett, Philip Morris, R.J. Reynolds, Lorillard (until 
DHHS responds to FTC request for recommendations as to whether and 
how to change the existing test method).
---------------------------------------------------------------------------

a. Basis for Opposition and Likely Effects of Rescission
    The industry comments stated three general bases for their 
opposition to the proposed rescission of the guidance. First, each of 
the companies stated that elimination of the current guidance will lead 
to consumer confusion, especially since the existing guidance has been 
in place for over 40 years.\24\ Second, most of the industry commenters 
indicated that a uniform test method is in the public interest.\25\ Two 
commenters stated that consumers would have no means for evaluating 
relative yields of cigarettes without a single standardized test 
method.\26\ One company indicated that elimination of the guidance 
could lead to a new ``tar derby'' in which companies would use 
different methods of measuring the yields in their cigarettes, thereby 
leading to greater consumer confusion.\27\ Third, three of the industry 
comments contended that Commission withdrawal of the guidance would be 
misguided in light of pending legislation that would give the U.S. Food 
and Drug Administration (``FDA'') jurisdiction over cigarette testing 
specifically and tobacco generally.\28\ These commenters stated that if 
the legislation is enacted, the FDA might decide to reinstate the 
Cambridge Filter method or impose a test method at odds with the 
Commission's proposal. Thus, Commission withdrawal of the guidance now 
could lead to two upheavals in a relatively short period of time, 
leading

[[Page 74503]]

to confusion and unnecessary industry expense.\29\ One company also 
said that rescission of the guidance was unwarranted because the 
Commission has not presented evidence demonstrating that consumers are 
misled by the yields derived from the current test method.\30\
---------------------------------------------------------------------------

    \24\ Liggett, Lorillard, Philip Morris, R.J. Reynolds.
    \25\ E.g., Philip Morris, Liggett, Lorillard.
    \26\ Philip Morris, Lorillard.
    \27\ Philip Morris.
    \28\ Liggett, Lorillard, R.J. Reynolds.
    \29\ E.g., R.J. Reynolds, Lorillard.
    \30\ Lorillard.
---------------------------------------------------------------------------

b. Require Additional Disclosures as an Alternative to Rescission
    Three of the industry comments recommended that the Commission 
consider the use of disclosures or disclaimers as an alternative to 
rescission of the guidance. These commenters stated that disclosures or 
disclaimers would reduce any perceived risk of consumer confusion as to 
the tar and nicotine yields obtained by the Cambridge Filter method. 
Liggett suggested that the FTC consider the use of qualifying 
information or disclosures. Lorillard recommended the use of 
disclaimers such as ``results may vary.'' Philip Morris stated that the 
Commission should consider publishing additional consumer education 
such as an FTC Consumer Alert explaining the limits of the Cambridge 
Filter method, or require specific disclosures or disclaimers that 
would decrease the likelihood of consumer confusion.
c. Use of Terms That State or Imply FTC Endorsement
    In its Federal Register Notice seeking public comment, the 
Commission stated that advertisers should no longer use the phrase ``by 
FTC Method'' or other terms or phrases that state or imply the 
Commission's approval or endorsement of the Cambridge Filter method, or 
yields derived from such method, if the 1966 guidance were rescinded. 
None of the cigarette companies, nor other commenters, raised any 
objections concerning this issue. Liggett requested guidance as to 
whether companies would be able to use terms such as ``by Cambridge 
Method'' as an alternative to ``by FTC Method.''
d. Effective Dates
    The industry comments noted that the Commission did not specify any 
effective date for compliance if the agency decided to withdraw its 
guidance. Most of these comments recommended that the FTC provide at 
least a one-year interim period.\31\
---------------------------------------------------------------------------

    \31\ Liggett, Philip Morris, and R.J. Reynolds.
---------------------------------------------------------------------------

III. DISCUSSION

    After considering all of the comments, the Commission has decided 
to withdraw its 1966 guidance. Advertisers who include statements of 
tar and nicotine yields as measured by the Cambridge Filter method must 
ensure that such claims comport with the FTC Act. In addition, 
advertisers should no longer use the phrase ``by FTC Method'' or other 
terms or phrases that state or imply the Commission's approval or 
endorsement of the Cambridge Filter method, or yields derived from that 
method or other machine-based test methods.
1. Basis for the Commission's Rescission of the 1966 Guidance
    The Commission has reached this decision for several reasons. 
First, the underlying premise for the Commission's guidance was that 
tar and nicotine statements based on the Cambridge Filter Method would 
help consumers make informed decisions by providing a metric for 
reducing their risk of adverse health effects from smoking. There is 
now a consensus among the public health and scientific communities that 
the Cambridge Filter method is sufficiently flawed that statements of 
tar and nicotine yields as measured by that method are not likely to 
help consumers make informed decisions. Thus, the underlying premise of 
the 1966 guidance is no longer valid.
    In addition, the Commission believes the statements of tar and 
nicotine yields as measured by this test method are confusing at best, 
and are likely to mislead consumers who believe they will get 
proportionately less tar and nicotine from lower-rated cigarettes than 
from higher-rated brands. The Commission will not allow its stamp of 
approval on a test method that is confusing or misleading to consumers.
    Finally, removal of any reference to the FTC should substantially 
improve consumer education efforts. It is difficult for the FTC or 
public health officials to discuss the limitations of ratings obtained 
pursuant to a test method that is stated to be a method apparently 
endorsed by an agency of the federal government. For example, the 
Commission's consumer alert on tar and nicotine yields conveys an 
overall message that consumers should not trust the tar and nicotine 
numbers, while at the same time, cigarette brand advertising implies 
that the FTC is endorsing those numbers.
2. The Proposed Alternatives Are Inadequate
    Given the inherent limits of the Cambridge Filter method, the 
Commission does not believe that retaining the guidance until approval 
of a new test method is a viable alternative. The FTC does not have the 
specialized scientific expertise needed to design and evaluate 
scientific test methodologies. Thus, when evaluating medical or other 
scientific issues, the Commission often relies on other governmental 
agencies and outside experts with more knowledge in the relevant area. 
Accordingly, in 1994, the Commission asked the NCI to convene a 
consensus conference to address cigarette testing issues, and, in 1998, 
the FTC asked the Department of Health and Human Services for 
recommendations concerning whether and how to change the test 
method.\32\ There currently does not appear to be a scientific 
consensus on these issues. Nor is there any anticipated date for 
reaching a resolution of these issues. Thus, simply waiting until the 
issues are resolved does not appear warranted or reasonable.
---------------------------------------------------------------------------

    \32\ See supra note 3.
---------------------------------------------------------------------------

    Similarly, the Commission is not convinced that simply amending the 
guidance to require the addition of disclosures or disclaimers is an 
adequate alternative to rescission of the guidance.
    Likewise, the Commission does not agree that rescission of the 
guidance is unwarranted or ill-advised because pending legislation 
would give the FDA jurisdiction over cigarette testing specifically, 
and tobacco generally. Legislation vesting the FDA with jurisdiction 
over tobacco products has been introduced annually for over a decade 
and has yet to be enacted.\33\ Most tobacco manufacturers have opposed 
that legislation, and it is not clear when such legislation may be 
enacted into law. Moreover, given the clear scientific consensus 
concerning the inherent limitations of the Cambridge Filter method, it 
is not likely that the FDA would reimpose a uniform system of cigarette 
testing that required use of the Cambridge Filter method as it exists 
today.
---------------------------------------------------------------------------

    \33\ The Commission notes that it has long recommended that 
Congress consider giving 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 Commerce, Science, and Transportation, United States 
Senate (November 13, 2007); Prepared Statement of the Federal Trade 
Commission Before the Committee on Energy and Commerce, Subcommittee 
on Commerce, Trade, and Consumer Protection, United States House of 
Representatives (June 3, 2003); Prepared Statement of the Federal 
Trade Commission Before the Committee on Government Reform, United 
States House of Representatives (June 3, 2003); Report to Congress 
for 1997, Pursuant to the Cigarette Labeling and Advertising Act 
(July 1999).

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

[[Page 74504]]

3. Requests for Guidance Concerning Future Tar and Nicotine Statements
    The comments submitted by the cigarette manufacturers requested 
guidance on several issues. In particular, Lorillard asked whether 
Commission rescission of its 1966 guidance would permit companies to 
include any statements of tar and nicotine yields in future cigarette 
advertisements.\34\ The Commission's rescission of its guidance does 
not prohibit statements of tar and nicotine yields as long as those 
claims are truthful, non-misleading, and adequately substantiated. If a 
claim is not likely to mislead, advertisers can generally make such a 
claim without running afoul of the FTC Act. At the same time, companies 
must ensure that their claims do not erroneously convey the impression 
that the stated yields are the amounts of tar or nicotine a consumer is 
actually likely to inhale from cigarette smoke, or convey an erroneous 
or unsubstantiated message that a relatively lower yield cigarette 
presents a reduced risk of harm.\35\
---------------------------------------------------------------------------

    \34\ Lorillard likewise asked whether companies were still 
required to state tar and nicotine yields in cigarette 
advertisements pursuant to a 1970 agreement among major cigarette 
manufacturers. The Commission notes that it is not a signatory to 
that agreement, and has never required statements of tar and 
nicotine yields in cigarette advertisements. See Brief of the United 
States as Amicus Curiae in Support of Respondent, Altria Group, Inc. 
v. Good, No. 07-562 (U.S. Sup. Ct. June 2008).
    \35\ For example, broad, unqualified claims that emphasize a 
product feature that may have no relative or actual significance or 
benefit to consumers, or that fail to disclose information necessary 
to eliminate a misleading impression, or that deceptively imply a 
comparative benefit could pose concerns under the FTC Act. See, 
e.g., Deception Policy Statement, appended to Cliffdale Associates, 
Inc., 103 F.T.C. 110, 174 (1984), cited with approval in Kraft, Inc. 
v. FTC, 970 F.2d 314 (7th Cir. 1992), cert. denied, 507 U.S. 909 
(1993).
---------------------------------------------------------------------------

    Liggett requested guidance as to whether companies could include 
reference to the ``Cambridge Filter method'' rather than the ``FTC 
method'' in any future advertisements. The Commission's rescission of 
its 1966 guidance does not prohibit companies from referencing the 
specific test method used to measure any stated yields of tar or 
nicotine. Future claims will be evaluated under the FTC Act's 
prohibition against deceptive acts or practices. Thus, companies can 
make claims that reference a specific test method as long as the claims 
are truthful, non-misleading, and substantiated. Companies should 
ensure that such claims do not falsely state or imply the FTC's 
endorsement or approval of that method.
4. Dates
    The Commission understands that packaging, advertising, and 
marketing materials that relied on the 1966 guidance may already be in 
channels of distribution and cannot be readily withdrawn. In the 
exercise of its prosecutorial discretion, the Commission does not 
intend to challenge actions taken in reliance on that guidance under 
circumstances in which altering or withdrawal of the materials was 
impracticable. Specifically, the Commission will not consider any 
challenges, prior to January 1, 2009, to materials that conformed to 
the 1966 guidance. Additionally, the Commission will not consider 
challenges to point-of-sale materials before March 1, 2009; to print 
advertisements that have already been distributed to publishers for 
publication before March 1, 2009; or to inventories of cigarette 
packaging distributed before March 1, 2009, to the extent that those 
packaging materials were printed before January 1, 2009.
5. Use of Descriptors
    Cigarette manufacturers have adopted descriptive terms such as 
``light'' and ``ultra low'' based on ranges of machine-measured tar 
yields. The Commission has neither defined those terms, nor provided 
guidance or authorization as to the use of descriptors. Thus, the 
Commission did not address, nor did it seek comment on, the use of 
descriptors in its July 14, 2008 Federal Register Notice. Nonetheless, 
a number of comments raised the use of descriptors. In particular, 
several of the comments supporting Commission rescission of the 1966 
guidance recommended that the Commission ban any use of 
descriptors.\36\ Several of the industry comments, on the other hand, 
requested guidance as to their continued use of descriptors.\37\
---------------------------------------------------------------------------

    \36\ E.g., American Academy of Pediatrics, American Legacy 
Foundation, O'Connor, Brandt.
    \37\ Liggett, Lorillard, R.J. Reynolds. Philip Morris indicated 
that it did not address the use of descriptors in its comment in 
light of the Commission's Federal Register Notice and on-going 
litigation.
---------------------------------------------------------------------------

    The Commission declines the invitation to initiate a proceeding 
that would prohibit all use of descriptors. Cigarette manufacturers 
have been banned from using descriptors by the trial judge in the RICO 
lawsuit brought by the U.S. Department of Justice,\38\ although that 
remedy is one of the issues currently before the court of appeals. 
Accordingly, Commission action to ban the use of descriptors appears 
unwarranted at this time.
---------------------------------------------------------------------------

    \38\ U.S. v. Philip Morris USA, Inc., 449 F. Supp. 2d 1 (D.D.C. 
2006).
---------------------------------------------------------------------------

    At the same time, any continued use of descriptors is subject to 
the FTC Act's proscription against deceptive acts and practices. To the 
extent that descriptors are used in a manner that conveys an overall 
impression that is false, misleading, or unsubstantiated, such use 
would be actionable. Thus, companies must ensure that any continued use 
of descriptors does not convey an erroneous or unsubstantiated message 
that a particular cigarette presents a reduced risk of harm or is 
otherwise likely to mislead consumers.

IV. CONCLUSION

    Based upon the analysis discussed above, the Federal Trade 
Commission has rescinded its 1966 guidance that it generally is 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.'' 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.
    By direction of the Commission.

Donald S. Clark
Secretary

CONCURRING STATEMENT OF COMMISSIONER PAMELA JONES HARBOUR

Regarding Federal Register Notice Rescinding the FTC's 1966 
Guidance Concerning the Cambridge Filter Method


    Today, the Commission has taken a bold step: removing its 
apparent imprimatur from cigarette advertisements. This action, 
while commendable, should only be a first step. Further action is 
needed.
    Contrary to recent criticism,\1\ the FTC has not been a passive 
player in the area of tobacco advertising. The Commission has long 
advocated for the development of a new test for tar and nicotine.\2\ 
The Commission has sought assistance from the scientific community 
to determine what changes should be made to the testing method. 
There still is no consensus on this issue, however, and this lack of 
agreement has led the Commission to rescind its outdated guidance.
---------------------------------------------------------------------------

    \1\ See Jerry Markon, Suit on Tobacco Ads Sparks Feisty Debate, 
Washington Post, Oct. 7, 2008, at A02.
    \2\ See Prepared Statement of the Federal Trade Commission 
Before the Committee on Commerce, Science, and Transportation, 
United States Senate (November 13, 2007), (http://www.ftc.gov/os/testimony/P064508tobacco.pdf).
---------------------------------------------------------------------------

    Tobacco companies will no longer be able to use terms indicating 
that the FTC approves

[[Page 74505]]

or endorses the Cambridge Filter Method. The Commission also has 
clarified that if tobacco firms choose to make claims based on this 
discredited testing method, these claims will not enjoy any 
presumption of legitimacy. Going forward, advertisements for 
cigarettes, like any other ads, will continue to be scrutinized 
under Section 5 of the FTC Act.
    Now that the FTC has removed its apparent imprimatur from the 
testing method, I urge the scientific community to redouble its 
efforts. Scientists must develop a test that provides consumers with 
a meaningful measure of the tar and nicotine yields of the 
cigarettes they smoke.
    More importantly, I urge the next Congress to reintroduce S. 
625, the Family Smoking Prevention and Tobacco Control Act. This 
bill includes several key consumer protection measures. First, the 
bill allows the Food and Drug Administration to regulate tobacco 
products. The FDA has lacked any authority in this area for decades, 
and tobacco manufacturers have exploited the void. The bill would 
authorize FDA scientists to track, analyze, and regulate the 
components of tobacco products. If this legislation is enacted, the 
FDA will wield more effective tools to protect public health.
    Second, the bill properly assigns authority to the FDA to issue 
certain regulations concerning tar and nicotine yields, including 
requirements governing the methodology for determining tar and 
nicotine yields and the public disclosure of information about such 
yields or other constituents of tobacco smoke. For more than 10 
years, the Commission has recommended to Congress that one of the 
government's science-based public health agencies be given 
jurisdiction over cigarette testing. The FDA clearly has the 
requisite scientific expertise for this task.
    Third, the bill appropriately preserves coordination between the 
FTC and the FDA in enforcing labeling and marketing requirements. 
This kind of enforcement is a core element of the FTC's consumer 
protection mission. The bill wisely preserves the FTC's jurisdiction 
over unfair or deceptive cigarette advertising.
    The regulation of the manufacture, sale, advertising, and 
marketing of tobacco products is a tall order, but it is crucial to 
the health of our country, especially its young people. Smoking is a 
continuing public health crisis. It deserves to be at the top of the 
new administration's public health agenda.

CONCURRING STATEMENT OF COMMISSIONER JON LEIBOWITZ

Regarding Rescission of Guidance on Cigarette Testing Methodology

    Our action today ensures that tobacco companies may not wrap 
their misleading tar and nicotine ratings in a cloak of government 
sponsorship. Simply put, the FTC will not be a smokescreen for 
tobacco companies' shameful marketing practices.
    For far too long, tobacco companies have advertised cigarettes 
using ``light'' and ``low tar'' descriptors based on machine-tested 
tar and nicotine results while knowing that the cigarettes, when 
actually smoked by people, would not deliver lower tar or 
nicotine.\1\
---------------------------------------------------------------------------

    \1\ In the U.S. Department of Justice lawsuit against the major 
tobacco companies under the Racketeer Influenced and Corrupt 
Organizations Act (``RICO''), U.S. District Court Judge Kessler 
ruled that the tobacco company defendants had ``falsely marketed and 
promoted low tar/light cigarettes as less harmful than full-flavor 
cigarettes in order to keep people smoking and sustain corporate 
revenues'' and that they ``internally recognized that low tar 
cigarettes are not less harmful than full-flavor cigarettes.'' 
United States v. Philip Morris USA, 449 F. Supp. 2d 1, 430, 456 
(D.D.C. 2006); see also id. at 430-561. The case is now on appeal.
---------------------------------------------------------------------------

    And for far too long, the tobacco industry has attempted to use 
the FTC imprimatur to imply government endorsement of the tar and 
nicotine ratings.\2\ The implication that this agency had mandated 
disclosure of the ratings furthered the misconception that the 
descriptors--and the ratings themselves--said something meaningful 
about the absolute or relative health characteristics of the 
cigarettes.\3\ To the contrary, the FTC has never required 
disclosure of tar and nicotine yields, nor authorized the use of 
descriptors.\4\
---------------------------------------------------------------------------

    \2\ For example, in defending against a class action lawsuit 
against manufacturers of ``light'' and ``low-tar'' cigarettes, 
Philip Morris wrongly asserted that the FTC ``has required tobacco 
companies to disclose tar and nicotine yields in cigarette 
advertising using a government-mandated testing methodology and has 
authorized them to use descriptors as shorthand references to those 
numerical test results.'' Brief for Petitioner Philip Morris at 2, 
Altria v. Good, No. 07-562 (U.S. Mar. 31, 2008).
    \3\ Tobacco company research conducted literally decades ago--
which was never presented to the Commission--indicated that lower 
tested yields did not entail a reduction in smoke intake. Brief for 
the United States as Amicus Curiae Supporting Respondents at 9, 
Altria v. Good, No. 07-562 (U.S. June 18, 2008). See also id. at 9-
11 (setting forth instances where tobacco companies failed to 
disclose to the Commission, or affirmatively downplayed, effects of 
compensation); Philip Morris, 449 F. Supp. 2d at 431 (``Defendants 
did not disclose the full extent and depth of their knowledge and 
understanding of smoker compensation to the public health community 
or to government regulators.'').
    \4\ See Brief for the United States as Amicus Curiae Supporting 
Respondents at 15, Altria v. Good, No. 07-562 (U.S. June 18, 2008).
---------------------------------------------------------------------------

    There's another benefit to our action today. Efforts to educate 
consumers about the facts behind cigarette ratings--i.e., that the 
ratings can't predict the amount of tar and nicotine a smoker gets 
from any particular cigarette, in part because smokers compensate 
for the lower tar and nicotine yield by inhaling more deeply and 
smoking longer\5\--will no longer have to battle a contrary message 
on cigarette advertisements that may have led to consumer confusion 
about what the ratings really mean.
---------------------------------------------------------------------------

    \5\ E.g., FTC Consumer Alert, Up in Smoke: The Truth About Tar 
and Nicotine Ratings, (www.ftc.gov/bcp/edu/pubs/consumer/alerts/alt069.pdf) (May 2000).
---------------------------------------------------------------------------

    After today, there should be no confusion: there is no such 
thing as a safe--or even a safer--cigarette.
[FR Doc. E8-28969 Filed 12-5-08: 8:45 am]
[Billing Code: 6750-01-S]