Tobacco Documents Online

WSA Mission To understand the science of smoking and health, communicate with the scientific community, evaluate proposed product changes, and guide reduced harm product development fvGSVffiiio~usdl/ WSA mission statement

WSA PROCESS FOR REDUCED-HARM Goals - Organization - Process - Focus SCoR Commercialization Team Meeting February 9, 2001 The presentation provides information about the current goals for harm reduction, the organization of WSA, the general process for making claims, and some of the current project areas in WSA to bring PM closer to making this happen.

Dose Response (Toxicity) Assessment Review of the literature and experimental data to derive the amount of reduction in a particular smoke constituent that would result in a decrease in biological activity. In the absence of such an analysis, our current recommendation is to achieve reductions of 90% or greater. Y41115Cdlf~uimMniq FeGwWmlrvrywCdS The next stage of the Risk Assessment is the dose response or toxicity assessment. This involves ....

WSA. Organization I • INBIFO • Product Integrity (PI) • Human Studies (HS) • Product Assessment (PA) • Regional Units (EU/Asia) 66£BVLS80Z ' Fa Diicuedai Aspom Only

Acceptability Testing • Concern Level II -Level I + -Genotoxicity -Cytotoxicity -Smoke Chemistry R . ~. ~-. _ i~~ FuLim®MFA~Y The next level of concerrr(level II) would include the same testing as level one plus genotoxicity (damage to genetic blueprint of the cell), cytotoxicity (cell death) and smoke chemistry which consists of about 50 compounds found in smoke that have be identified by IARC and or the Consumer Products Safety Commission as probable or known human carcinogens

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WSA Organization • INBIFO • Product Integrity (PI) • Human Studies (HS) • Product Assessment (PA) • Regional Units (EU/Asia) uaisuc~~nw.,n7~n 5 Groups that make up WSA INBIFO - laboratory group does testing PI - reviews materials that make up products for approval HS - exposure assessment PA - rolls it (the above) all together Regional Units - deal with issues that arise in the EU and Asia regions -

Smoking and Harm Reduction "We agree with the overwhelming medical and scientific consensus that cigarette smoking causes lung cancer and other serious diseases: " w ~.o , ,om .ra "We take the pursuit of harm reduction as a priority. We are pursuing harm reduction in a responsible way. We welcome involvement of the public health community." R5A presentatlonlo WHO "We will develop and launch a conventional cigarette with a significant reduction in potentially harmful smoke constituents by the middle of 2002." Sbaem.a~~ Addr~.r~ ~M vsro~aaxcuiamnamamu.na raum.~rm+..ah Overhead shows PM's statements regarding Smoking and Harm Reduction. There has been an evolution over time and it is reflected here. The top quote is from the PM web site. The next three bullets are from Rick's presentation to WHO. The last is a statement made during Mike Szymanczyk's State of the Business Addresses, December 7, 8, 11, 2000 Also made public to Financial Investors.

Acceptability Testing ,~_ -- =tT =t+~~.~ • Concern Level I -Disclosure -Analysis for potential contribution to smoke by pyrolysis 29V1 $'MCmumiW~slwAMni FuLVmuaPUP'm'Vly The toxicity assessment is done in a tiered approach with the level of testing inereasing with the concern level. Concern level I is the lowest of the concern levels and would involve ....

r:.=. ;..a Exposure Assessment Substance Amount _ _ _-_,_ Fxposure Frequency Exposure Route 1 .. ~~...~.~~ _".~.- . PoNu;atiori Studies Switching Studies M, s~C~4a~ The exposure assessment portion of the risk assessment paradigm is something new for PM. Here we are looking at Human studies - the amount someone gets, how often, how long and how they are exposed (route). We are planning two types of studiespopulation and switching studies.