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Review of Ingredients Added to Cigarettes
Sponsor: Philip Morris U.S.A.
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Public Concerns
• Are ingredients added to cigarettes changing the relative risk of smoking?
• Scientific problem: Pyrolysisproducts of ingredients
• Scientific problem: Inhalation route of administration
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Logical Possibilities
• Direct effect of inhaled ingredient and/or its pyrolysis products
• Change in matrix of smoke chemistry
• Change in smoking behavior
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Three Phases Negotiated
• Feasibility• Scientific criteria
• Ingredient reviews
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Mechanisms of Objectivity• Contracts – LSRO controls
– Selection of experts– Contents of reports– Publication of reports
• Independence of directors• Independence of experts• Peer review emphasis• Transparency emphasis• Formal reviews of potential conflicts
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Comprehensive Reviews
• Both staff-driven documents and expert reviews (negotiation)
• Not a review of a Philip Morris’s document
• Not a review of a Philip Morris’s program
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Added Ingredients Review Committee Roster
• Carroll E. Cross, M.D. • Shayne Cox Gad, Ph.D., D.A.B.T., A.T.S. • Donald E. Gardner, Ph.D., F.A.T.S. • Louis D. Homer, M.D., Ph.D. • Rudolph Jaeger, Ph.D., D.A.B.T., B.C.F.M. • Robert Orth, Ph.D.• Resha M. Putzrath, Ph.D., D.A.B.T. • Emanuel Rubin M.D. • James L. Schardein, M.S. • Thomas Joseph Slaga, Ph.D.
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Past AIRC Meetings
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• October, 2001-Washington, DC
• November, 2001-Conference Call
• December, 2001-Chicago
• January, 2002-Dallas
• February, 2002-Washington, DC
• May, 2002-Richmond
Documents Reviewed• More than 1,800 articles in
database (both hard copy & electronic versions)
• More than 65 articles reviewed by AIRC
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Poster Presentations
• CORESTA - Meeting (09/22/02-09/27/02)
• TSRC - Meeting (09/30/02-10/02/02)
• SOT (in preparation)
Tentative Report Structure1-Executive Summary2-Introduction3-Physics & Chemistry of Cigarette Smoke4-Human Exposure 5-Adverse Human Health Effects of Cigarettes6-Principles of Testing7-Chemical & Biological Test Data8-Research Needs9-Conclusions10-CitationsAppendices
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Ch
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Public Meeting Rationale
• Peer review
• Transparency
• Add to information base (response to questions)
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Feasibility Questions
(1) Feasible to develop review criteria?
(2) Estimate meaningful relative risks for non-tobacco ingredients?
(3) Appropriate criteria for review?
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Notice of Public Meeting
• Science Ad
• Invitation letters
• List servers
• Other websites
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Value Added• Bridge between scientific community
and organizations seeking advice
• Independent, objective advice
• Professional scientists
• Previous reports accepted by federal agencies
• Publication widely available
• Answers to some complex, important questions
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LSRO ReportsGenerally Recognized As Safe
(GRAS) Ingredients
• Select Committee On GRAS Substances
- Reviewed 238 compounds
- Produced 151 reports
• Now: Pyrolysis Products
• Now: Inhalation Route
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Daniel M. Byrd III, Ph.D., D.A.B.T.
Deputy Director
Life Sciences Research Office
T: (301) 530-7034
F: (301) 571-1876
Contact
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