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CORESTA Meeting, Smoke Science/Product Technology, 2013, Seville, ST 23

Insights from initial analysis for harmful and potentially harmful constituents (HPHC) in cigarette and smokeless tobacco products

WAGNER K.A.; DESOI D.; MORTON M.J.; OLDHAM M.J.
Altria Client Services Inc., Richmond, VA, U.S.A.

A total of 20 commercial cigarette and 16 commercial smokeless tobacco products were initially assayed for 96 HPHC (Draft HPHC list, Federal Register, August 12, 2011) prior to draft guidance by FDA (March 30, 2012). The FDA Draft Guidance specified a reduced list of HPHC with more replicates than initially tested. Three contract laboratories were used to complete all testing. The same lots of commercial product were used for all testing. Cigarettes were tested using both the ISO and Canadian intense smoking regimens. In general, the levels of HPHC constituents in the commercial products tested were consistent with levels previously reported in the literature. Approximately 40% of HPHC measured for cigarettes and 35% of HPHC measured for smokeless tobacco products were not found or were below the limit of quantification. Average relative standard deviations among replicates can vary widely for constituent measurements above LOQ. Comparison of initial HPHC results with results from additional replicates for both cigarettes and smokeless tobacco products demonstrated statistically significant differences for most HPHC (i.e. temporal variability within a laboratory) despite each assay being validated within a laboratory and the assay being present on their ISO 17025 accreditation.

These differences demonstrate the need for standardized methods between laboratories with defined repeatability and reproducibility determined by inter-laboratory collaborative testing for each HPHC using certified reference standards. These differences also mean 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.