Moist Snuff Products Research Articles

Harmful and potentially harmful constituents (HPHCs) in two novel nicotine pouch products in comparison with regular smokeless tobacco products and pharmaceutical nicotine replacement therapy products (NRTs)

BackgroundTobacco-free nicotine pouches is a novel category of oral nicotine-delivery products. Among current tobacco users such pouches may serve as a low-risk alternative to cigarettes or conventional, tobacco-based oral products e.g., snus and moist snuff. In the United States (U.S.), the market leading nicotine-pouch brand is ZYN®. However, no data on the chemical characteristics of ZYN have been published.MethodsWe screened for 43 compounds potentially present in tobacco products in seven oral nicotine-delivery products: ZYN (dry and moist), snus (General®), moist snuff (CRP2.1 and Grizzly Pouches Wintergreen), and two pharmaceutical, nicotine replacement therapy products (NRTs, Nicorette® lozenge and Nicotinell® gum). Thirty-six of the tested compounds are classified as harmful and potentially harmful constituents (HPHCs) by the Center for Tobacco Products at the U.S. Food and Drug Administration (FDA-CTP). Five additional compounds were included to cover the GOTHIATEK® product standard for Swedish snus and the last two compounds were chosen to include the four primary tobacco specific nitrosamines (TSNAs).ResultsThe tested products contained nicotine at varying levels. The two ZYN products contained no nitrosamines or polycyclic aromatic hydrocarbons (PAHs) but low levels of ammonia, chromium, formaldehyde, and nickel. In the NRT products we quantified low levels of acetaldehyde, ammonia, cadmium, chromium, lead, nickel, uranium-235, and uranium-238. The largest number (27) and generally the highest levels of HPHCs were quantified in the moist snuff products. For example, they contained six out of seven tested PAHs, and seven out of ten nitrosamines (including NNN and NNK). A total of 19 compounds, none of which were PAHs, were quantified at low levels in the snus product. NNN and NNK levels were five to 12-fold lower in snus compared to the moist snuff products.ConclusionsNo nitrosamines or PAHs were quantified in the ZYN and NRT products. Overall, the number of quantified HPHCs were similar between ZYN and NRT products and found at low levels.

Development and Validation Of A Discriminatory Dissolution Method for Portioned Moist Snuff and Snus

Portioned moist snuff and snus, two subcategories of smokeless tobacco products (STP) were dissolution tested as a quality control test. A USP Apparatus 4 was employed to develop and validate the method. The method was assessed based on time to reach nicotine dissolution plateau, percentage difference between two profiles at each time point, relative standard deviation (RSD), and f1 (similarity) and f2 (dissimilarity) values. Based on these criteria, 200 ml volume and 8 ml/min flow were found be discriminatory. The amount of nicotine dissolved from the nine products varied widely (2.0-3.4, 2.1-4.1, 3.3-4.6, 5.5-6.6, 6.9-9.1, 11.5-14.2, 12.5-14.6, 14.0-15.5, and 15.5-19.6 mg/pouch at 60 min). RSDs of the dissolution ranges were more than 20% at earlier time points and less than 20% at later timepoints. The developed method produced distinct profiles for all the tested products, which was further confirmed by f1>15 and f2<50 values. In conclusion, the developed method was discriminatory and can be employed as a quality control test and to differentiate among moist snuff and snus products.

‘No-Barriers’ tobacco product? Selling smokeless tobacco to women, people of colour and the LGBTQ+ community in the USA

BackgroundIn both Sweden and the USA, smokeless tobacco (ST) is legal and used predominantly by men. Starting in the 1970s, US tobacco companies attempted to expand the ST market to...

Potential Application of USP Paddle and Basket Dissolution Methods in Discriminating for Portioned Moist Snuff and Snus Smokeless Tobacco Products.

The focus of the study was to develop discriminatory dissolution methods for portioned snus and moist snuff sub-categories of smokeless tobacco products (STPs) using USP basket and paddle apparatuses. Skoal Classic Wintergreen (SCW) and CORESTA CRP1.1 pouches were used as test products. The dissolution was performed at 10, 20, 30, 40, and 50rpm basket or paddle speed in 500ml artificial saliva pH6.8. The products were also characterized for assay, pH, particle size, and loss on drying. The dissolution profiles were evaluated for amount/% of nicotine dissolved, time to reach plateau, and profiles comparison by f2 and f1 factors. The nicotine assay was 13.3 ± 0.2 and 7.6 ± 0.1mg/pouch for SCW and CRP1.1, respectively. The nicotine dissolved in 30min from SCW and CRP1.1 were 38.4-81.8 and 37.6-88.1, and 50.5-64.9 and 72.3-92.1% by paddle and basket methods, respectively. The f2 and f1 values were ≤ 39.2 and ≥42.1 and ≤ 43.2 and ≥34.1 for basket methods and paddle methods. RSD were less than 20% at all points of dissolution profiles, and dissolution plateau were achieved in 30min at some of the tested conditions. In summary, dissolution methods based on basket and paddle can be used as a performance test for STPs.

Examining Market Trends in Smokeless Tobacco Sales in the United States: 2011-2019.

The smokeless tobacco (SLT) industry in the U.S. continues to transform with novel products amid an evolving regulatory environment. We report SLT sales trends in the U.S. by analyzing retail market scanner data from 2011 through 2019. National SLT sales data were obtained from Nielsen's Convenience Track System for January 2011 to December 2019. UPC codes were used to classify products by attributes including type, parent company, brand, form, and flavor. Market share was calculated as percentage of total unit sales. Detailed product analysis was presented for moist snuff, snus, and tobacco-free nicotine products. SLT sales increased by 5.8% between 2011 and 2016 but declined by 3.9% from 2016 to 2019. Moist snuff sales increased by 8.1% between 2011 and 2016 and then declined 7.4% from 2016 to 2019 but still accounted for roughly 90% of the overall market annually. Between 2011 and 2019, snus sales consistently increased while sales of chew, dry snuff, and dissolvables decreased. Tobacco-free nicotine products emerged in 2016 and captured 4.0% of the market by 2019. Portion pouch packaging and flavors showed consistent growth although their popularity varied by the type of smokeless product. This study extends our previous work on U.S. SLT market trends through 2019. Overall sales increased between 2011 and 2016 but there were signs of leveling off including declining sales of moist snuff. Newer products continue to gain market share. Continued monitoring of SLT sales is needed, particularly given the new modified risk status of several products. This study analyzed the last 9 years of smokeless tobacco market data (2011-2019) to describe recent trends in sales. Overall, the smokeless product category is quite resilient although signs suggest downward trends among some product categories and features. New types of smokeless tobacco products (eg, snus and tobacco-free nicotine pouches) account for a growing share of the market.

Extraction from Moist Snuff with Artificial Saliva of Benzo[a]pyrene and Other Polycyclic Aromatic Hydrocarbons

Summary The present study evaluated in vitro extractability of various polycyclic aromatic hydrocarbons (PAHs) from moist snuff, when the extracting agent was water or artificial saliva. The extraction was performed on nine brands of moist snuff samples that are commercially available and were purchased from the market in January 2018. The moist snuff brands were selected to represent brands with different tobacco cut size descriptors and flavors. For the measurement of PAHs, two different analytical methods were used, an HPLC (High Performance Liquid Chromatography) method for measuring only benzo[a]pyrene (BaP) and a GC/MS/MS (Gas Chromatography Tandem Mass Spectrometry) method for measuring 21 PAHs (including BaP). These methods were modifications of preexistent methods reported in the literature. The results for BaP indicated that by extracting 500 mg of freeze-dried moist snuff with 6 portions of 20 mL water (120 mL), or with 4 portions of 20 mL artificial saliva, followed by two portions of 20 mL water, the BaP remains close to 100% in the solid material and it is not detected in the extracting solution. PAHs with a molecular weight similar or heavier than BaP also showed no extractability. Lighter PAHs such as fluorene, phenanthrene, anthracene, and 5-methylanthracene showed a relatively good extractability. An intermediate group including fluoranthene, pyrene, and benz[a]anthracene showed some extractability in the conditions of this in vitro experiment. This study is not a substitute for clinical studies regarding PAH uptake in human users of moist snuff. However, the results indicate very limited bioavailability of BaP and heavier PAHs from moist snuff. Higher, but variable bioavailability was indicated for lighter PAHs. Important implications of these findings are that: 1) measurably different BaP content of two moist snuff products is unlikely to result in any meaningfully different consumer exposure to BaP; and 2) biomarkers for one PAH cannot necessarily be used as a reliable indicator of exposure to another PAH, particularly if the molecular weights of the precursor PAHs differ since their bioavailabilities can be very different. [Beitr. Tabakforsch. Int. 28 (2019) 214–223]

Application of modified cloud point extraction method for the chromium speciation in artificial saliva extracts of different snuff products

A modified cloud point extraction method (m-CPE) was developed for the speciation of chromium species (Cr3+ and Cr6+) in artificial saliva extracts (ASE) of snuff products. In this method, Cr3+ was complexed with 8-hydroxyquinoline, which was trapped in nonionic surfactant (Triton X-114), prior to analyzed by electrothermal atomic absorption spectrometer (ETAAS). Whereas, the total extractable Cr was determined by reducing Cr6+ to Cr3+ using Na2SO3 as a reducing reagent. Several parameters were optimized for the developed m-CPE. Under the most favorable conditions, enrichment factor, enhancement factor and limit of detection for the proposed method were 60, 134 and 0.04μgL−1, respectively having relative standard deviation <5%. Health risks associated with the intake of total Cr in snuff products was also assessed. Estimated daily intake of Cr via sniffing 10g/day of dry and moist snuff products was found below the maximum tolerable daily intake whereas the calculated risk for cancer due to Cr was observed in the acceptable range of 10 E−6–E−4.

Bacterial Populations Associated with Smokeless Tobacco Products.

It is estimated that there 8 million users of smokeless tobacco products (STPs) in the United States; however, there are limited data on microbial populations that exist within these products. The current study was undertaken to better understand the potential microbiological risks associated with STP use and provide a baseline microbiological profile of STPs. Several bacterial species were identified that are of possible concern due to their potential to cause opportunistic infections. In addition, some species have abilities to reduce nitrates to nitrites, which may be an important step in the formation of carcinogenic tobacco-specific N'-nitrosamines. Overall, this report provides a microbiological baseline to help fill knowledge gaps related to the microbiological risks of STPs and to inform potential regulations regarding the manufacture and testing of STPs.

A Survey of N'-Nitrosonornicotine (NNN) and Total Water Content in Select Smokeless Tobacco Products Purchased in the United States in 2015.

This investigation provides an updated survey measuring the levels of N'-nitrosonornicotine (NNN) and water content of a select number of smokeless tobacco products sold in the United States in 2015. A total of 34 smokeless tobacco products were collected and analyzed for NNN and water content using LC-MS/MS and GC-TCD, respectively. Smokeless tobacco products were chosen to obtain a representative sample of the different types of products on the U.S. market. These smokeless products represent 12 of the 25 top-selling smokeless tobacco products according to 2013 Nielsen net sales data while five of the smokeless tobacco products are of lower selling smokeless tobacco products. The NNN levels and the water content of the smokeless tobacco products were determined and compared to previous studies. Although the range of NNN levels found was broad for the examined smokeless tobacco products (0.64-12.0 μg/g dry weight), dry snuff had the highest levels of NNN observed (>5 μg/g dry weight). We observed a general decrease in NNN levels for the same six moist snuff products that were analyzed in 2004 compared to our current 2015 study. The water content of the smokeless tobacco products surveyed ranged from 3.92 to 54.8%.

Chemical and toxicological characteristics of conventional and low-TSNA moist snuff tobacco products.

Use of smokeless tobacco products (STPs) is associated with oral cavity cancer and other health risks. Comprehensive analysis for chemical composition and toxicity is needed to compare conventional and newer STPs with lower tobacco-specific nitrosamines (TSNAs) yields. Seven conventional and 12 low-TSNA moist snuff products purchased in the U.S., Sweden, and South Africa were analyzed for 18 chemical constituents (International Agency for Research on Cancer classified carcinogens), pH, nicotine, and free nicotine. Chemicals were compared in each product using Wilcoxon rank-sum test and principle component analysis (PCA). Conventional compared to low-TSNA moist snuff products had higher ammonia, benzo[a]pyrene, cadmium, nickel, nicotine, nitrate, and TSNAs and had lower arsenic in dry weight content and per mg nicotine. Lead and chromium were significantly higher in low-TSNA moist snuff products. PCA showed a clear difference for constituents between conventional and low-TSNA moist snuff products. Differences among products were reduced when considered on a per mg nicotine basis. As one way to contextualize differences in constituent levels, probabilistic lifetime cancer risk was estimated for chemicals included in The University of California's carcinogenic potency database (CPDB). Estimated probabilistic cancer risks were 3.77-fold or 3-fold higher in conventional compared to low-TSNA moist snuff products under dry weight or under per mg nicotine content, respectively. In vitro testing for the STPs indicated low level toxicity and no substantial differences. The comprehensive chemical characterization of both conventional and low-TSNA moist snuff products from this study provides a broader assessment of understanding differences in carcinogenic potential of the products. In addition, the high levels and probabilistic cancer risk estimates for certain chemical constituents of smokeless tobacco products will further inform regulatory decision makers and aid them in their efforts to reduce carcinogen exposure in smokeless tobacco products.

Characterization of Bacterial Communities in Selected Smokeless Tobacco Products Using 16S rDNA Analysis.

The bacterial communities present in smokeless tobacco (ST) products have not previously reported. In this study, we used Next Generation Sequencing to study the bacteria present in U.S.-made dry snuff, moist snuff and Sudanese toombak. Sample diversity and taxonomic abundances were investigated in these products. A total of 33 bacterial families from four phyla, Actinobacteria, Firmicutes, Proteobacteria and Bacteroidetes, were identified. U.S.-produced dry snuff products contained a diverse distribution of all four phyla. Moist snuff products were dominated by Firmicutes. Toombak samples contained mainly Actinobacteria and Firmicutes (Aerococcaceae, Enterococcaceae, and Staphylococcaceae). The program PICRUSt (Phylogenetic Investigation of Communities by Reconstruction of Unobserved States) was used to impute the prevalence of genes encoding selected bacterial toxins, antibiotic resistance genes and other pro-inflammatory molecules. PICRUSt also predicted the presence of specific nitrate reductase genes, whose products can contribute to the formation of carcinogenic nitrosamines. Characterization of microbial community abundances and their associated genomes gives us an indication of the presence or absence of pathways of interest and can be used as a foundation for further investigation into the unique microbiological and chemical environments of smokeless tobacco products.

Smokeless tobacco products sold in Massachusetts from 2003 to 2012: trends and variations in brand availability, nicotine contents and design features

BackgroundSales of smokeless tobacco products have increased in the USA. More than one in eight males in the 12th grade are current users of smokeless tobacco. Surveillance data examining nicotine...

Examining market trends in the United States smokeless tobacco use: 2005–2011

BackgroundWhile cigarette consumption in the USA continues to decline, promotion for and consumption of smokeless tobacco (SLT) is growing. However, little research has explored what product features are driving SLT...

Applying toxicological risk assessment principles to constituents of smokeless tobacco products: implications for product regulation

ObjectiveTo determine how information on chemical constituents of different smokeless tobacco products (STPs) may be used in cancer risk assessment for regulatory purposes.MethodsThis study investigated select STP constituents potentially associated...

Smokeless tobacco and oral cancer: a review of the risks and determinants.

Smokeless tobacco has been associated with oral cancer for many decades. The purpose of this article is to review research relevant to this association, including epidemiologic studies, studies of putative carcinogens such as tobacco-specific nitrosamines (TSNAs) and other contaminants, and possible cancer inhibitors. Epidemiologic studies addressing this issue primarily consist of case-control studies. They show that the use of chewing tobacco and moist snuff is associated with very low risks for cancers of the oral cavity and related structures (relative risks [RR] from 0.6 to 1.7). The use of dry snuff is associated with higher RRs, ranging from 4 to 13, while the RRs from smokeless tobacco, unspecified as to type, are intermediate (RR = 1.5 to 2.8). With regard to TSNAs, historical levels in American moist snuff products were higher than those in their Swedish counterparts, but levels in contemporary products are uniformly low. TSNA levels in chewing tobacco have always been low, but levels in dry snuff have been higher, including some very high levels in current products. In general, smokeless tobacco users are not exposed to significant levels of cadmium, lead, benzo(a)pyrene, polonium-210, and formaldehyde, when compared with concentrations of these compounds in foods. Finally, low oral cancer risk from smokeless tobacco use may be influenced by the presence of cancer inhibitors, mainly anti-oxidants, in smokeless tobacco products.

The relative buffering capacities of saliva and moist snuff: implications for nicotine absorption.

Commercial moist snuff products are used by placing a portion of tobacco inside the mouth between the inner cheek or lip and gum. Nicotine is absorbed into the blood stream via transfer across various oral membranes including the buccal mucosa (cheek lining). The resulting salivary pH when a given moist snuff product is placed in the mouth is an important factor for nicotine absorption because it will affect the proportion of free base nicotine that is readily available for absorption. The resulting salivary pH for a given moist snuff product will be determined in part by the relative acid-base buffering capacities of the saliva and moist snuff, as well as the pHs of the saliva and moist snuff prior to coming in contact with one another. In the current study, the acid-base buffering capacities (mu eq/g) of a series of commercial moist snuff products were determined and compared to the acid-base buffering capacity for unstimulated, whole human saliva. The buffering capacities of the moist snuff products were determined to be 10-20 times higher than the buffering capacity of human saliva. The resulting salivary pH ranges after contact between an artifical saliva and the various moist snuff products were also determined; the results were used to predict the proportion of free base nicotine that can be expected to occur in the mouth during the first few minutes of product use. These studies provide a basis for examining and understanding the effects that moist snuff product pHs and buffering capacities may be expected to have on nicotine absorption.

Determination of Nicotine, pH, and Moisture Content of Six US Commercial Moist Snuff Products--Florida, January-February 1999

The use of smokeless tobacco (moist snuff and chewing tobacco) can cause oral cancer and precancerous oral lesions (leukoplakia) and is a risk factor for cardiovascular diseases and nicotine addiction. Despite these adverse effects, smokeless tobacco is used commonly in the United States by young people, especially male high school students. Officials in Florida requested CDC assistance in analyzing six moist snuff products to measure three factors that affect their nicotine dose: pH, nicotine content, and moisture content. This report summarizes the results of the analysis, which indicate that the pH, amount of nicotine, and moisture vary widely among brands.

Determination of Nicotine, pH, and Moisture Content of Six US Commercial Moist Snuff Products—Florida, January-February 1999

Determination of Nicotine, pH, and Moisture Content of Six US Commercial Moist Snuff Products—Florida, January-February 1999

In vitro effects of smokeless tobacco extract on tumor necrosis factor- α (TNF- α) and interleukin-1 β (I l-1 β) production, and on lymphocyte proliferation

The use of smokeless tobacco (moist snuff) products is associated with mucosal lesions, gingival recession, attachment loss, and oral cancer. Despite numerous reports on the general toxic effects of smokeless tobacco extract, little information is available regarding the specific effects of smokeless tobacco on immune response. Inflammatory cytokines released as a result of smokeless tobacco-induced irritation may play a role in the development of oral mucosal lesions at habitual tobacco placement sites in smokeless tobacco users. Consequently, the purpose of this study was to determine whether an aqueous extract of smokeless tobacco (STE) affects the secretion of tumor necrosis factor- α (TNF- α), interleukin -1 β (I L-1 β), and the proliferation of lymphocytes. A macrophage cell line (J774-A1) was used to measure the effects of STE on tumor necrosis factor- α (TNF- α) and interleukin -1 β (I L-1 β) secretion. Mouse splenocytes were used to assess the effects of STE on lymphocyte proliferation. We found that STE at low concentrations enhanced the production of both TNF- α and I L-1 β. Furthermore, STE at similar concentrations enhanced mitogen-induced murine splenocyte proliferation. Overall, these data suggest that smokeless tobacco upregulated two key proinflammatory cytokines and also induces lymphocyte proliferation.

Review of the evidence that pH is a determinant of nicotine dosage from oral use of smokeless tobacco.

OBJECTIVE: To determine whether manipulation of the pH of moist-snuff products by manufacturers could control the delivery of nicotine. DATA SOURCES: Medline database 1966-97 using the following subject headings and...