This is part of an occasional series that recalls some of the stories reported 10 years ago in the News section of the Journal.
The International Organization for Standardization (ISO) machine-based cigarette test for determining the tar, nicotine, and carbon monoxide content of cigarettes should be banned and replaced with new testing methods because the test's results are misleading to consumers, the World Health Organization's Study Group on Tobacco Product Regulation (TobReg) concluded at its inaugural meeting this past October.
A special ad hoc committee of the President's Cancer Panel reached a similar conclusion 10 years ago when it met to examine the accuracy and appropriateness of the Federal Trade Commission's cigarette test, the U.S. equivalent of the ISO test.
Despite the ad hoc committee's recommendations and later research supporting their conclusions, cigarette companies today are still using results of that same ISO/FTC cigarette test in their advertising, and research aimed in part at developing recommendations for changes or replacements to the test is just now beginning.
The FTC developed its measurement system in 1966 to provide a ranking of the tar, nicotine, and carbon monoxide levels in domestic cigarettes. Cigarette companies placed the tar and nicotine ratings in their advertising, and the FTC released an annual report compiling the ratings of the various brands. The FTC stopped their in-house testing of cigarettes in the 1980s but continued to compile their annual report from data given to them by the tobacco companies. However, its last report was issued in 2000, covering the year 1998, and "there hasn't been one issued since the last one," said Michael Ostheimer, an attorney with the FTC. Ostheimer declined to explain why the FTC stopped issuing the annual report.
In 1997, the FTC proposed changes to its cigarette test, but the public comments they received raised serious technical and health policy issues, including whether there was any relationship between lower tar and nicotine levels in cigarettes and a reduction in health risks. The next year, the secretary of the FTC asked the Department of Health and Human Services (HHS) to develop specific recommendations for changing the cigarette test.
To help HHS develop these recom-mendations, the National Cancer Institute's Tobacco Control Research Branch produced a monograph in 2001 that evaluated the risks associated with smoking cigarettes that were classified as low-yield based on the FTC test (see News, Vol. 94, No. 3, p. 162). At the time of the monograph's release, NCI announced that it and HHS would form a working group to review the science and determine what changes should be made to the FTC test.
More than 3 years later, HHS has yet to make any recommendations. "It hasn't moved along as quickly as we'd have liked," said Scott Lieschow, Ph.D., chief of NCI's Tobacco Control Research Branch. There is no real consensus on what needs to be done, and "we don't know what a real alternative to the FTC method would be," he said.
Whether a machine-based test is even appropriate is the subject of debate. "There are real questions about whether we really need a standard test," said Lynn T. Kozlowski, Ph.D., professor and head of the Department of Biobehavioral Health at Pennsylvania State University in University Park.
Kozlowski likened the FTC test to trying to measure caloric intake by inventing an eating machine. A better method, he said, might be to study changes in people after eating. Similarly, studying the effects of cigarettes in actual people may be better than using a machine-based system. "In other words, cut out the machine smoker as the middleman," he said.
"There's not really one method, one-size-fits-all," said Mirjana V. Djordjevic, Ph.D., a program director in NCI's Tobacco Control Research Branch and member of the TobReg. The TobReg recommended that a replacement to the ISO test include several types of information, including cigarette design, smoking topographyor how people use the productand measurement of biomarkers.
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NCI's collaboration with the WHO and other agencies is just one part of its approach to determining exactly what should replace the FTC test, said Lieschow. The Tobacco Control Research Branch has created a "harm reduction network" to look at how key research questions should be addressed, particularly in light of the introduction of new tobacco products that make implied claims of reduced harms.
In addition, earlier this year NCI funded seven new tobacco use research centers that will address various issues, including the identification of biomarkers of tobacco exposure. And NCI recently got approval for a $3 million request for proposalsnew funding that will be applied to research on cigarette use in the real world. "We have to look at the testing of cigarettes in a larger context," said Lieschow.
Whatever the research shows to be the best method for measuring the effects of cigarette smoking in humans, it could be many years before HHS makes any actual recommendations on a replacement to the FTC test. "There's no way of knowing when we're going to have sufficient data to make a recommendation," said Lieschow.
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