New Testing and Evaluation Process Developed For Potential Reduced-Risk Tobacco Products

Latest report by LSRO identifies available biological testing methods

for evaluating potential reduced-risk tobacco products

BETHESDA, MD – Despite the well-known risks of smoking, 45 million Americans still light up each year. Nearly two-thirds of smokers want to stop, and more than one-third will try to quit, but less than three percent of those who try to quit will be successful. For those unable or unwilling to quit, some tobacco companies have marketed tobacco-based cigarette substitutes that are intended to reduce the health risks associated with cigarette smoking. However, no comprehensive evaluation process to examine the biological effects of these potential reduced-risk tobacco products (PRRTPs) has been described.

New Report Issued by LSRO

A team of independent scientists and physicians, affiliated with the Maryland-based Life Sciences Research Office (LSRO;, today announced they had critically reviewed and identified preclinical and clinical methods that can be used to examine the biological effects of PRRTPs. Their findings, conclusions, and recommendations for the use of various approaches in comprehensive PRRTP assessments are presented in the latest LSRO report entitled, Biological Effects Assessment in the Evaluation of Potential Reduced-Risk Tobacco Products. The report was produced under a contract between Philip Morris USA, Inc. (Philip Morris) and LSRO, but the findings, conclusions, and recommendations were developed independently of Philip Morris and represent the views of LSRO alone. The current report is the second of three developed by LSRO to evaluate potential testing methods for cigarettes and PRRTPs.

Key Findings, Conclusions, and Recommendations

  • PRRTP assessments should focus on the risks posed by the three most deadly diseases caused by cigarette smoking: lung cancer, chronic obstructive pulmonary disease, and cardiovascular disease.
  • Preclinical (genotoxicity and cytotoxicity assays and animal studies) and clinical studies are necessary to evaluate the potential health impact of PRRTPs on smokers.
  • Assays for Salmonella mutagenicity, in vitro chromosomal damage, and in vitro cytotoxicity can provide useful information for evaluating PRRTPs.
  • Animal studies should be used to assess PRRTPs prior to conducting clinical studies. The development of animal models for lung cancer, chronic obstructive pulmonary disease, and cardiovascular disease is an active and promising research area.
  • PRRTPs that demonstrate a potential to reduce toxicological effects relative to conventional cigarettes in preclinical testing can proceed to 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.
  • Of all the testing methods assessed, biomarkers of biological effect are weighted the most in assessing the risk reduction potential of a PRRTP.

Primary Consideration in Assessments of PRRTPs

According to LSRO’s Executive Director Michael Falk, “In addition to preclinical studies, postmarketing population assessment studies, consisting of a combination of clinical, behavioral, and epidemiological methods, will be necessary to detect the public health consequences that may result from the introduction 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. In our view, the high risk of death and disease currently borne by smokers should be the primary consideration in premarketing assessments of PRRTPs.”

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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.

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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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