Exposure Assessment For Potential Reduced-Risk Tobacco Products

BETHESDA, MD - (April 3, 2008) - Cigarette smoking causes lung cancer, chronic obstructive pulmonary disease, cardiovascular disease, and a host of other diseases. For this reason, non-smokers have been advised to never start smoking and smokers to quit smoking. Since less than 3 percent of smokers who try to quit smoking annually successfully quit, some tobacco companies have developed new cigarette and cigarette-like products intended to reduce exposure to tobacco smoke constituents and lower the health risks associated with cigarette smoking. However, no framework exists to comprehensively assess exposures to cigarette smoke constituents resulting from use of these potential reduced-risk tobacco products (PRRTPs).

New Report Issued by LSRO
The current report, Exposure Assessment in the Evaluation of Potential Reduced-Risk Tobacco Products, is the third and final report developed by a team of independent scientists and physicians affiliated with the Life Sciences Research Office (LSRO;http://www.LSRO.org). Produced under a contract between Philip Morris USA, Inc. and LSRO, this report identifies and evaluates methods that can be used to measure the exposures arising from use of cigarettes and PRRTPs.

Key Findings, Conclusions, and Recommendations Preclinical (product characterization, tobacco product and smoke chemistry) and clinical studies are necessary to evaluate exposure resulting from PRRTP usage.

Product characterization studies are an important early step in PRRTP evaluation and should guide chemistry and biomarker studies.

Chemistry studies should be conducted on smoke generated using at last two cigarette smoking machine regimens.

A broad analytical screen should be conducted on cigarette smoke.

A battery of biomarkers that reflects exposure to both particulate and vapor phase smoke constituents should be used in clinical studies.

Biomarkers of biological effect should be used in clinical studies to monitor changes that occur in biological processes as a result of PRRTP use.

Biomarkers of exposure are weighted the most of all the methods evaluated for assessing the risk reduction potential of a PRRTP.

Primary Consideration in Assessments of PRRTPs

According to LSRO's Executive Director Michael Falk, “Preclinical studies and postmarketing population assessment studies are necessary to comprehensively assess the public health consequences of PRRTPs.” Falk continued, saying “Both short-term and long-term studies should be conducted to assess the overall impact of the PRRTP on the smoking population.”


For nearly half a century, the Life Sciences Research Office (LSRO) has provided expert, objective scientific opinions and evaluations to governmental agencies and leading corporations in the food, health and bioscience sectors. A non-profit organization originally established in 1962, LSRO provides independent science-based analysis and advice that has proven integral to the development of sound policies and regulations on the national and international level.


This study will be of interest to academic, government and industry researchers; tobacco control and public health organizations; agencies with regulatory oversight of tobacco products, such as the Federal Trade Commission; and individuals involved in the development of legislation providing regulatory authority over tobacco products, public health organizations and their staff. The report will also be of interest to current smokers.


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