Toxicity Testing Plan for Low Ignition-potential Cigarettes

Both mainstream and sidestream cigarette smoke are complex chemical mixtures. In view of this chemical complexity, it should be no surprise that cigarette smoke has multiple, diverse effects on human health. Nor should it be unexpected that multiple chemicals in cigarette smoke contribute to any single adverse health effect. The diverse human health consequences of cigarette smoking are briefly reviewed. Many experimental laboratory models have been developed to study the mechanisms of cigarette smoke-induced disease. These laboratory models are not always convertible into practical, standardized test systems that quantitatively compare one cigarette prototype with another. In view of the multiplicity of health effects and mechanisms of smoke-induced health damage, no single test or battery of tests can capture all possible health endpoints. While analyses of smoke constituents and studies in laboratory animals are feasible, human epidemiological studies are not practical for short-term assessment of small differences in the toxic effects of various cigarette prototypes. Cigarette smoke samples for chemical analysis and biological testing need to be collected in a manner that approximates human cigarette puffing as closely as technically feasible. In formulating a testing plan, the CPSC essentially has two options: a design-based testing plan, in which individual, pre-selected cigarette design parameters, such as paper porosity or percent expanded tobacco, are systematically varied and tested; and a performance-based testing plan, in which complete cigarette prototypes, and not individual design parameters, are evaluated. Some testing protocols entail a "screening paradigm." Multiple tests are performed in sequence. If a prototype fails any particular test in the sequence, the prototype is rejected and no further tests are performed. Other multi-test protocols allow for tradeoffs among costs and benefits. An unfavorable result at any point along the testing sequence does not necessarily result in rejection. commercial cigarette brands is the measurement and reporting of "tar," nicotine and carbon monoxide in mainstream smoke by the Federal Trade Commission. With this exception, none of the toxicity tests described by the Expert Panel are routinely performed on existing cigarette brands by any governmental agency. The contents of currently marketed cigarettes are proprietary information. Specific additives, tobacco The only governmentally-mandated, health-oriented testing of