An evaluation of the variability of HPHCs in cigars as compared to cigarettes
In May 2016, the U.S. Food and Drug Administration (FDA) issued a final rule to deem cigars to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). As part of this regulation, the FDA will require manufacturers to report the quantities of harmful and potentially harmful constituents (HPHCs) in cigar filler and smoke. The diversity of the cigar product category adds challenges to the measurement of HPHCs. CORESTA has developed recommended methods for nicotine and CO for cigars; however, standardized methods do not exist for other HPHCs. Consensus methods, with defined repeatability and reproducibility (r&R), do exist for many of the abbreviated list HPHCs in cigarettes. However, these methods have not been shown to be fit for purpose for the analysis of cigars. We will present data that demonstrate that HPHC variability in cigar testing is greater than that observed for cigarette testing. This presentation will cover some of the factors that affect cigar testing variability including smoke collection, variation in physical properties, and tip styles. In order to effectively test cigars for HPHCs and define the uncertainty of the reported results, the three pillars of effective analytical testing need to be implemented: consensus standardized methods with defined r&R, proficiency testing, and reference products.