Evaluation of the 1R6F certified reference cigarette for proficiency testing of mainstream smoke parameters

Abstract

A goal of the cooperative agreement between the U.S. Food and Drug Administration and the Center for Tobacco Reference Products (CTRP) at the University of Kentucky was to produce a standard reference cigarette for researchers to further tobacco science. The 1R6F certified reference cigarette for analytical testing was developed to be typical of an American blend cigarette. The cigarettes have been used in proficiency testing (PT) schemes under the supervision of the CTRP since 2016 for a variety of parameters. Data were compared from 8 rounds of PT schemes submitted by participating laboratories, which include various international stakeholders comprised of academic institutions, federal research/regulatory laboratories, tobacco product manufacturers, and independent contract testing laboratories. Evaluation of the datasets for harmful and potentially harmful constituents (HPHCs) within the mainstream smoke of the 1R6F certified reference cigarette included tobacco-specific nitrosamines (TSNA), tar, nicotine, and carbon monoxide (TNCO), and Benzo[α]pyrene (BαP). Of the datasets evaluated, less than 5 % resulted in either a warning or alert, and less than 2 % resulted in an alert. Comparisons across multiple PT rounds revealed no significant differences in the consensus means of the tested parameters. Evaluation of data submitted by participating laboratories for multiple proficiency test rounds shows that the 1R6F certified reference cigarette is an acceptable material as a control reference for the analysis of HPHCs which is imperative since some stakeholders may be required to participate in, and receive satisfactory results, from PT for accreditation purposes.