Assessment of Mouth-Level Exposure to Tobacco Constituents in U.S. Snus Consumers

Caraway, John W.; Chen, P. X.

doi:10.1093/ntr/nts187

Cited by 10 publications

(11 citation statements)

References 18 publications

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“…Our results, as well as others [10,12,14], show that extraction of snus constituents by users is a variable process, with SDs ranging from approximately 20% to 70% of the mean percentage extraction (Table 3). The inability to compare the constituent content of a single pouch before and after use introduces errors due to the variability of unused pouches.…”

Section: Discussionsupporting

confidence: 83%

“…Most recently, Caraway and Chen studied constituent extraction by 53 users of three similar U.S. pouched snus products [14]. Despite almost identical baseline levels of total TSNAs, a lower mean extraction was observed (21.6 ± 21.4%) compared to our study (35.8 ± 7.9%).…”

Section: Discussioncontrasting

confidence: 70%

“…The results of this study, and others [10,12-14,16], indicate that further research is needed in this area. For example, to understand more fully both the importance of usage time and the possible consequences of extreme usage durations on snus constituent extraction would require a dedicated time-course study covering usage durations from 20 to 120 min [7].…”

Section: Discussionmentioning

confidence: 47%

“…In such studies, subjects use snus in a normal or timed manner [10,12-14]. Chemical analysis of each portion after use, and comparison with the content of matched unused snus portions, allows estimation of the amount of constituents extracted during snus use.…”

Section: Introductionmentioning

confidence: 99%

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Multi-analyte approach for determining the extraction of tobacco constituents from pouched snus by consumers during use

Digard

Gale

Errington

et al. 2013

Chemistry Central Journal

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BackgroundSnus is a smokeless oral tobacco product with a significant history of use in Sweden, where it is regulated under food legislation. Users place a small porous sachet or a pinch of loose snus between the upper jaw and cheek for approximately one hour, leading to partial intake of tobacco constituents. To understand user exposure to tobacco, a multi-analyte approach based on the extraction of pouches by methanol, ethanol and water was validated and applied to the measurement of various constituents, including nicotine, four tobacco-specific nitrosamines (TSNAs), propylene glycol, water, ammonium, nitrate, sodium, chloride, linalool, citronellol, linalyl acetate and geraniol, extracted from snus pouches during use by human consumers.ResultsAfter validation against established single-analyte methods, the multi-analyte approach was used to determine constituent levels in snus pouches before and after one hour of use. Although the concentrations in the snus pouches varied from nanogram (e.g. TSNAs) to milligram (e.g. nicotine, sodium and propylene glycol) quantities (25.1 ng to 35.3 mg per 1 g pouch), the mean percentage extracted varied only from 19.2% for linalyl acetate to 37.8% for the TSNA 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) among all constituents analyzed. The TSNAs, some of which are known carcinogens, showed the highest percentage extraction (range 34.6%–37.8%). Measurement variability was low for all analytes, ranging from 2.4% (total TSNAs, NAT) to 9.5% (geraniol). By contrast, inter-subject variability ranged from 6.7% (NAB) to 52.2% (linalyl acetate), and was greater than 20% for eight of the constituents analyzed. Intra-subject variability ranged from 3.4% (citronellol) to 29.7% (geraniol).ConclusionsGenerally, less than a third of each constituent tested was extracted during one hour of snus use, independent of constituent concentration. The variable nature of in-use extraction was shown to be driven by inter-subject variability. The results provide insight into possible mechanisms controlling constituent extraction in the mouth during snus use, and provide reference data for the development of in-vitro laboratory systems for estimating extraction of tobacco constituents from snus.

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Section: Discussionsupporting

confidence: 83%

Section: Discussioncontrasting

confidence: 70%

Section: Discussionmentioning

confidence: 47%

Section: Introductionmentioning

confidence: 99%

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Multi-analyte approach for determining the extraction of tobacco constituents from pouched snus by consumers during use

Digard

Gale

Errington

et al. 2013

Chemistry Central Journal

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“…The used pouches and lot-matched unused pouches were sent to Labstat ® International ULC for analysis of the levels of nicotine, nornicotine, anatabine, B[a]P, NNK, NNN, N'-nitrosoanabasine (NAB), and N'-nitrosoanatabine (NAT), and trace metals (data not shown). The methods used for constituent determination are described in CARAWAY and CHEN (23). The quantities of constituents remaining in the used pouches obtained from each subject were subtracted from the average quantity present in lot-matched unused pouches to estimate the amounts of each constituent removed during use.…”

Section: Mouth-level Exposures From Use Of Stpsmentioning

confidence: 99%

Changes in Biomarkers of Exposure and Subjective Effects When Smokers Switch to Dual Use of Cigarettes and Either Snus or a Dissolvable Tobacco Product: A Summary of Three Clinical Studies

Round

Campbell

Stiles

et al. 2015

Beiträge Zur Tabakforschung International/Contributions to Tobacco Research

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SUMMARYA series of ambulatory clinical studies were conducted to evaluate changes in biomarkers of tobacco exposure and subjective product ratings when adult smokers switched to dual use of cigarettes with Camel Strips (Strips), Camel Sticks (Sticks), or Camel (SNUS). In all studies, subjects smoked ad libitum for one week (baseline). In incremental stages over three subsequent weeks, subjects were instructed to reduce cigarettes per day (CPD) by at least 75% and include use of one type of smokeless tobacco product (STP). Product use data was recorded by subjects daily, questionnaires were administered and smoked cigarette filters and used snus pouches were collected weekly, and 24-hour urine samples were collected at baseline and the end of dual use for measurement of biomarkers of tobacco exposure. In total, 100 subjects were enrolled, and 88 completed the studies. At the end of dual use, mean CPD reductions of approximately 60% were reported in all studies. Median levels of biomarkers of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and acrolein either did not statistically significantly change or showed statistically significant decreases in all studies. Serum and urinary nicotine biomarkers did not significantly change. Twentyfive additional biomarkers were measured only in the SNUS study. Of those, 18 biomarkers statistically significantly decreased 12.4-35.7%. No statistically significant increases in biomarker levels were observed in any of the studies. Decreases in some biomarkers confirmed that smoking reductions occurred but were less than the reported CPD reductions. Mouth-level exposure estimates suggest subjects did not significantly alter their puffing behavior to compensate for decreased CPD. Acceptability ratings of cigarettes decreased significantly during dual use, while ratings of Strips and SNUS increased, suggesting that the change in use behavior affected subjects' perceptions of the products. Results from these studies suggest that smokers who switch to dual use with either dissolvable tobacco or snus will likely not increase tobacco constituent exposure and may reduce exposure to some tobacco toxicants, especially those associated with combustion. [Beitr. Tabakforsch. Int. 26 (2015)

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Quantitative risk assessment of tobacco products: A potentially useful component of substantial equivalence evaluations

Marano

Liu

Fuller³

et al. 2018

Regulatory Toxicology and Pharmacology

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Quantitative risk assessment (QRA), a scientific, evidence-based analytical process that combines chemical and biological data to quantify the probability and potential impact of some defined risk, is used by regulatory agencies for decision-making. Thus, in tobacco product regulation, specifically in substantial equivalence (SE) evaluations, QRA can provide a useful, practical, and efficient approach to address questions that might arise regarding human health risk and potential influence on public health. In SE reporting, when differences in product characteristics may necessitate the determination of whether a new product raises different questions of public health, the results from QRA are a valuable metric. An approach for QRA in this context is discussed, which is modeled after the methodology for assessment of constituent mixtures by the US Environmental Protection Agency for environmental Superfund site assessment. Given the intent in both cases is an assessment of the public health impact resulting from the totality of exposure to a mixture of constituents, the application is appropriate. Although some uncertainties in the information incorporated may exist, relying on the most appropriate of the available data increases the confidence and decreases the uncertainty in the risk characterization using this data-driven methodology.

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Assessment of Mouth-Level Exposure to Tobacco Constituents in U.S. Snus Consumers

Cited by 10 publications

References 18 publications

Multi-analyte approach for determining the extraction of tobacco constituents from pouched snus by consumers during use

Multi-analyte approach for determining the extraction of tobacco constituents from pouched snus by consumers during use

Changes in Biomarkers of Exposure and Subjective Effects When Smokers Switch to Dual Use of Cigarettes and Either Snus or a Dissolvable Tobacco Product: A Summary of Three Clinical Studies

Quantitative risk assessment of tobacco products: A potentially useful component of substantial equivalence evaluations

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