Overall Plan

The Life Sciences Research Office (LSRO) is undertaking an independent, third party review of the health effects and relative risk of selected ingredients added to cigarettes. This review will be sponsored by Philip Morris, USA (PM).

The overall plan for accomplishing this review is divided into three phases. LSRO has agreed to conduct Phase 1, a review of the feasibility; an evaluation of the scope of the program and development of a technical approach. Preliminary investigations by LSRO have revealed a scientific controversy about the risks of the ingredients and what methods should be employed to assess those risks. Phase 2 will include establishing review criteria, setting forth the structure of the review process, and publishing a report on the findings. Phase 3 will be an independent, third party review of specific ingredients as selected by the sponsor. Each of these phases will be negotiated separately without obligation to proceed to subsequent phases.

Phase 1

Phase 1 will include an investigation into the methods of producing cigarettes, identifying the ingredients added in the manufacture of cigarettes, biological endpoints and current methodologies for evaluating the risks of cigarette smoking and potential future endpoints and methodologies. Other questions that may be addressed include: how should total body burden be evaluated; should subpopulations be considered; how should interactions between ingredients be evaluated; and should environmental smoke be included? The goal of Phase 1 will be to ascertain whether it is feasible to pursue the development of review criteria and whether a meaningful estimate of relative risk can be ascertained. To arrive at this goal the LSRO will identify and convene an Expert Panel with appropriate disciplinary coverage, review the extant literature and data, organize and present an open scientific conference and call for public input and comment, and report on the findings of the Expert Panel.

The Relationship between LSRO and PM

PM, as sponsor, will be responsible for providing: funding, background information about the tobacco industry, all the data in their possession on the composition and safety of the ingredients to be reviewed, and other resources as necessary to the successful conduct of the review. LSRO, as the organization conducting the reviews, will be responsible for assembling panels of experts, supporting the expert panels with staff and facilities, conducting the studies and reviews, collecting and disbursing public submissions, making the data publicly available, conducting an independent review of the literature and supporting evidence, convening an open scientific conference, collecting and analyzing public comment, and publishing the final reports.

In order to preserve the third party independence of the review, after the agreement has been executed, PM will have no further role in the design, conduct, deliberations, or the conclusions of the panels. PM retains limited fiduciary oversight; supplies information on request; and, has the option to review the final reports for inadvertent inclusion of confidential information. All private communications between PM and LSRO will be restricted to authorized individuals and will be logged. Private communication between PM and members of the Expert Panels will be prohibited.

PM will be contractually prohibited from use of, or reference to LSRO reviews, studies, or reports as endorsement of any product or ingredient. The use of the LSRO name or logos for marketing, advertising, or any other purpose will be prohibited without the express permission of LSRO. PM will agree not to publicly refer to the review or reports without reference to the availability of the report.

Participation by Other Interested Parties

In principle, broad acceptance and the overall value of the process may be greatly enhanced by including broader participation by other parties such as individuals and agencies of federal and state government, professional societies and associations, and other tobacco manufacturers,. Participation might take the form of co-sponsorship (with or without contributing additional resources), contributing information, or making available the official auspices of the participating organization. Incentives for increasing participation by other interested parties should be incorporated into all agreements. Should other parties want to be a part of this process, both LSRO and PM will agree on a case by case basis on the nature and extent of their participation and how the form of participation will be recognized.

Goal and Guiding Principles

The primary goal of this review is to provide a measure of the relative risk of the ingredients (other than tobacco) added to cigarettes. The parties agree that the review will be conducted under principles of openness, inclusiveness, independence, and scientific objectivity:

  • The review will be conducted so as to allow public comment and to make the data, decisions, and reports of the panels publicly available.
  • The review will be structured as an independent, third-party review. Although support for the conduct of the review will be derived largely via the sponsorship of PM, the LSRO will conduct the selection of expert panels, development of review standards, criteria, and procedures, and the conduct of the reviews in a manner that is neither restricted nor influenced by PM or other sponsors.
  • All decisions will be made on the basis of objective scientific judgment, offered by unbiased experts qualified on the basis of their knowledge and accomplishments, and based on all available scientific data.
  • The review will not address the safety of smoking cigarettes or other tobacco products nor weigh the risk of exposure to any individual manufactured product.