review of ingredients added to cigarettes overview kara lewis, ph.d. staff scientist

Review of Ingredients Added to Cigarettes

Overview

Kara Lewis, Ph.D.

Staff Scientist

Introduction

• Epidemiology shows that cigarette smoking associates with premature human mortality

• Effect of added ingredients is unknown

Definition of Added Ingredient

A substance other than tobacco that is added

to a cigarette

LSRO Approach

Assess relative risk of adverse health effects

Relative Risk

sdx

NS sd

xNS sd

xNS Risk (+)

ingredient Risk (-)ingredient

LSRO approachExpert Panel

Carroll E. Cross, M.D.

Division of Pulmonary and Critical Care Medicine

University of California, School of Medicine 

Shayne C. Gad, Ph.D., D.A.B.T.

Gad Consulting Services

Donald E. Gardner, Ph.D., F.A.T.S.

Inhalation Toxicology Associates  

Louis D. Homer, M.D., Ph.D.

Holladay Park Medical Center 

Rudolph J. Jaeger, Ph.D., D.A.B.T.

Environmental Medicine, Inc.

Robert Orth, Ph.D.

Apis Discoveries, LLC.

Resha M. Putzrath, Ph.D., D.A.B.T. (Retired)

Georgetown Risk Group

 Emanuel Rubin, M.D.

Department of Pathology, Anatomy, and Cell Biology

Thomas Jefferson University

James L. Schardein, M.Sc., F.A.T.S.

Independent consultant

Thomas J. Slaga, Ph.D.

AMC Cancer Research Center and

Center for Causation and Prevention

LSRO Approach

• Convened 11 times to date

• Reviewed more than 3000 publications• Worldwide literature

• Clinical studies

• Government reports

• Books

• Received 21 scientific presentations

Project Structure

Phase I: Determination of Feasibility

Phase II: Development of Scientific Criteria

Phase III: Reviews of Individual Ingredients

• Determined whether testing ingredients

added to cigarettes is feasible

• Reviewed published literature covering•Smoke chemistry and physics

•Exposure

•Adverse health effects

•Issues and methods in testing

Phase I - Feasibility

Phase I - Conclusions

• Testing is feasible and worthwhile.

• Publication of the Phase I report is imminent.

Framework to guide the process of testing ingredients added to cigarettes

Phase II – Scientific Criteria

Phase III - Reviews of Individual Ingredients

•Use the criteria developed in Phase II

•Process:

–Literature review

–Data analysis

• Compare cigarettes with and without added

ingredients

• This approach is feasible

• Phase II is underway

Summary