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Insights from analysis for harmful and potentially harmful constituents (HPHCs) in tobacco products

DOI: 10.1016/j.yrtph.2014.06.017
Title: Insights from analysis for harmful and potentially harmful constituents (HPHCs) in tobacco products
Journal Title: Regulatory Toxicology and Pharmacology
Volume: 70
Issue: 1
Publication Date: October 2014
Start Page: 138
End Page: 148
Published online: online 25 June 2014
ISSN: 0273-2300
Author: Michael J. Oldham, Darren J. DeSoi, Lonnie T. Rimmer, Karl A. Wagner, Michael J. Morton
Affiliations:
  • Altria Client Services, 601 East Jackson Street, Richmond, VA 23261, USA
  • Abstract: 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 4–6 months 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.
    Received: 14 April 2014
    Abbreviations: 1,2,3,4,6,7,8-HpCDD, 1,2,3,4,6,7,8-heptachlorodibenzo-p-dioxin; 1,2,3,4,6,7,8-HpCDF, 1,2,3,4,6,7,8-heptachlorodibenzo-p-furan; 1,2,3,4,7,8,9-HpCDF, 1,2,3,4,7,8,9-heptachlorodibenzo-p-furan; 1,2,3,4,7,8-HxCDD, 1,2,3,4,7,8-hexachlorodibenzo-p-dioxin; 1,2,3,4,7,8-HxCDF, 1,2,3,4,7,8-hexachlorodibenzo-p-furan; 1,2,3,6,7,8-HxCDD, 1,2,3,6,7,8-hexachlorodibenzo-p-dioxin; 1,2,3,6,7,8-HxCDF, 1,2,3,6,7,8-hexachlorodibenzo-p-furan; 1,2,3,7,8,9-HxCDD, 1,2,3,7,8,9-hexachlorodibenzo-p-dioxin; 1,2,3,7,8,9-HxCDF, 1,2,3,7,8,9-hexachlorodibenzo-p-furan; 1,2,3,7,8-PeCDD, 1,2,3,7,8-pentachlorodibenzo-p-dioxin; 1,2,3,7,8-PeCDF, 1,2,3,7,8-pentachlorodibenzo-p-furan; 2,3,4,6,7,8-HxCDF, 2,3,4,6,7,8-hexachlorodibenzo-p-furan; 2,3,4,7,8-PeCDF, 2,3,4,7,8-pentachlorodibenzo-p-furan; 2,3,7,8-TCDD, 2,3,7,8-tetrachlorodibenzo-p-dioxin; 2,3,7,8-TCDF, 2,3,7,8-tetrachlorodibenzo-p-furan; A-α-C, 2-amino-9H-pyrido[2,3-b]indole; CDC, Centers for Disease Control and Prevention; CORESTA, Cooperation Centre for Scientific Research Relative to Tobacco; CRP2, CORESTA Reference Product 2; FDA, US Food and Drug Administration; GC/MS, gas chromatography–mass spectrometry; Glu-P-1, 2-amino-6-methyldipyrido[1,2-a:3′,2′-d]imidazole; Glu-P-2, 2-aminodipyrido[1,2-a:3′,2′-d]imidazole; HPHC, harmful and potentially harmful constituent; HPLC, high performance liquid chromatography; ICP-MS, inductively coupled plasma mass spectroscopy; IQ, 2-amino-3-methylimidazo[4,5-f]quinoline; ISO, International Organization for Standardization; LC–MS/MS, liquid chromatography–mass spectroscopy–mass spectroscopy; LOD, limit of detection; LOQ, limit of quantification; MEA-α-C, 2-amino-3-methyl-9H-pyrido[2,3-b]indole; MCS, mainstream cigarette smoke; GC/MS/MS, gas chromatograph–mass spectroscopy–mass spectroscopy; NDEA, N-nitrosodiethylamine; NDELA, N-nitrosodiethanolamine; NDMA, N-nitrosodimethylamine; NMEA, N-nitrosomethylethylamine; NMOR, N-nitrosomorpholine; NNK, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone; NNN, N-nitrosonornicotine; NPIP, N-nitrosopiperidine; NPYR, N-nitrosopyrrolidine; NSAR, N-nitrososarcosine; OCDD, octachlorodibenzo-p-dioxin; OCDF, octachlorodibenzo-p-furan; PAHs, polyaromatic hydrocarbons; PhIP, 2-amino-1-methyl-6-phenylimidazo[4,5-b]pyridine; total TCDD, total tetrachlorodibenzo-p-dioxin; total-HpCDD, total heptachlorodibenzo-p-dioxin; total-HpCDF, total heptachlorodibenzo-p-furan; total-HxCDD, total hexachlorodibenzo-p-dioxin; total-HxCDF, total hexachlorodibenzo-p-furan; total-PeCDD, total pentachlorodibenzo-p-dioxin; total-PeCDF, total pentachlorodibenzo-p-furan; total-TCDF, total tetrachlorodibenzo-p-furan; TPM, total particulate matter; Trp-P-1, 3-amino-1,4-dimethyl-5H-pyrido[4,3-b]indole; Trp-P-2, 1-methyl-3-amino-5H-pyrido[4,3-b]indole
    Corresponding information:
    Email: Michael.J.Oldham@altria.com SciencePublications@altria.com

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