Daily Rules, Proposed Rules, and Notices of the Federal Government
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
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.
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.
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,
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—
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.
Given the serious limitations of the existing test method, the Commission published a
The Commission received 36 comments in response to its
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.
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.
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.
The Commission received comments opposing its proposal from the four major domestic cigarette manufacturers, and three 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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,
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.
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.
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,
Tobacco companies will no longer be able to use terms indicating that the FTC approves
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.
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.
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.
There’s another benefit to our action today. Efforts to educate consumers about the facts behind cigarette ratings—
After today, there should be no confusion: there is no such thing as a safe—or even a