title: Insights from analysis for harmful and potentially harmful constituents (HPHCs) in tobacco products.
abstract: A total of 20 commercial cigarette and 16 commercial smokeless tobacco products were assayed for 96 compounds listed as harmful and potentially harmful constituents (HPHCs) by the US Food and Drug Administration. For each product, a single lot was used for all testing. Both International Organization for Standardization and Health Canada smoking regimens were used for cigarette testing. For those HPHCs detected, measured levels were consistent with levels reported in the literature, however substantial assay variability (measured as average relative standard deviation) was found for most results. Using an abbreviated list of HPHCs, statistically significant differences for most of these HPHCs occurred when results were obtained 4-6months apart (i.e., temporal variability). The assay variability and temporal variability demonstrate the need for standardized analytical methods with defined repeatability and reproducibility for each HPHC using certified reference standards. Temporal variability also means that simple conventional comparisons, such as two-sample t-tests, are inappropriate for comparing products tested at different points in time from the same laboratory or from different laboratories. Until capable laboratories use standardized assays with established repeatability, reproducibility, and certified reference standards, the resulting HPHC data will be unreliable for product comparisons or other decision making in regulatory science.
authors: Altria Client Services, 601 East Jackson Street, Richmond, VA 23261, USA. Electronic address: Michael.J.Oldham@altria.com.
authors: Michael J
authors: MJ
authors: Oldham
authors: Altria Client Services, 601 East Jackson Street, Richmond, VA 23261, USA.
authors: Darren J
authors: DJ
authors: DeSoi
authors: Altria Client Services, 601 East Jackson Street, Richmond, VA 23261, USA.
authors: Lonnie T
authors: LT
authors: Rimmer
authors: Altria Client Services, 601 East Jackson Street, Richmond, VA 23261, USA.
authors: Karl A
authors: KA
authors: Wagner
authors: Altria Client Services, 601 East Jackson Street, Richmond, VA 23261, USA.
authors: Michael J
authors: MJ
authors: Morton
mesh_terms: D002170:Canada; D006801:Humans; D012015:Reference Standards; D015203:Reproducibility of Results; D062789:Tobacco Products / Q000009:adverse effects / Q000032:analysis*; D014030:Tobacco, Smokeless / Q000009:adverse effects / Q000032:analysis*; D014481:United States; D014486:United States Food and Drug Administration
keywords: Assay variability; Cigarettes; Harmful and potentially harmful constituents; Smokeless tobacco