Grass roots approach to control levels of carcinogenic nitrosamines, NNN and NNK in smokeless tobacco products.

Due to the extensive ban on public smoking, tobacco companies focused their business on new smokeless tobacco (SLT) products promoting them as a harm reduction strategy and a safer alternative to cigarettes. Two nitrosamines, N'-nitrosonornicotine (NNN) and nicotine-derived nitrosamine ketone (NNK), present in SLT, listed as group 1 human carcinogens by the International Agency for Research on Cancer, are found to be the prime agents for most of cancers in SLT users. This review illustrates the mechanism of cancer induction by NNN and NNK in humans along with factors influencing the formation of NNN and NNK at various stages of tobacco manufacturing. It reveals the high levels and wide variations of NNN and NNK found among the diverse variety of SLT products sold worldwide. According to a recent report by FDA- Centre for Tobacco Products, reducing levels of nitrosamines in SLT products could greatly enhance the quality of life by reducing mortality, morbidity and medical expenditures due to cancer. For the first time, grass root approaches to minimize the levels of NNN and NNK in tobacco, from plant growth to the finished products, have been systematically compiled as they have the potential to contribute to reducing tobacco related disease burden.

Aluminum in Tobacco Products Available in the United States.

A quantitative method for the analysis of aluminum in tobacco products was developed, validated and applied to select samples. Samples were prepared using standard microwave digestion of tobacco from various products. Detection and quantification utilized sector field inductively coupled plasma-mass spectrometry. Method applicability to analyze aluminum in a range of tobacco products was demonstrated with quantitative analyses of smokeless tobacco products, cigarette tobacco, little cigar tobacco and roll-your-own/pipe tobacco. Though these products represent a convenience sampling, we observed that smokeless tobacco products, as a category, had the lowest average aluminum concentrations. Roll-your-own or pipe tobacco and little cigar tobacco had higher median and ranges of aluminum concentrations than cigarette and smokeless tobacco samples.

Consortium on Methods Evaluating Tobacco: Research Tools to Inform US Food and Drug Administration Regulation of Snus.

Introduction: The US Food and Drug Administration (FDA) has purview over tobacco products. To set policy, the FDA must rely on sound science, yet most existing tobacco research methods have not been designed to specifically inform regulation. The NCI and FDA-funded Consortium on Methods Evaluating Tobacco (COMET) was established to develop and assess valid and reliable methods for tobacco product evaluation. The goal of this article is to describe these assessment methods using a US manufactured "snus" as the test product. Methods: In designing studies that could inform FDA regulation, COMET has taken a multidisciplinary approach that includes experimental animal models and a range of human studies that examine tobacco product appeal, addictiveness, and toxicity. This article integrates COMET's findings over the last 4 years. Results: Consistency in results was observed across the various studies, lending validity to our methods. Studies showed low abuse liability for snus and low levels of consumer demand. Toxicity was less than cigarettes on some biomarkers but higher than medicinal nicotine. Conclusions: Using our study methods and the convergence of results, the snus that we tested as a potential modified risk tobacco product is likely to neither result in substantial public health harm nor benefit. Implications: This review describes methods that were used to assess the appeal, abuse liability, and toxicity of snus. These methods included animal, behavioral economics, consumer perception studies, and clinical trials. Across these varied methods, study results showed low abuse-liability and appeal of the snus product we tested. In several studies, demand for snus was lower than for less toxic nicotine gum. The consistency and convergence of results across a range of multi-disciplinary studies lends validity to our methods and suggests that promotion of snus as a modified risk tobacco products is unlikely to produce substantial public health benefit or harm.

Reducing tobacco-related harm: FDA's proposed product standard for smokeless tobacco.

This Special Communication discusses the Food and Drug Administration's (FDA's) proposed rule that would limit N-nitrosonornicotine (NNN) levels in smokeless tobacco products. It argues that finalising and implementing this first 'product standard' would mark a significant step forward in the FDA's efforts to reduce tobacco-related harms.

Gas Chromatography-Mass Spectrometry Method to Quantify Benzo[a]Pyrene in Tobacco Products.

The USA Food and Drug Administration (FDA) established benzo[a]pyrene (B[a]P) as a harmful and potentially harmful constituent (HPHC) found in tobacco products. Tobacco manufacturers are required to report HPHC quantities to the FDA; however, there is currently no standardized method for determination of B[a]P in smokeless tobacco products (STPs). This work details a sensitive, selective and rapid method for the determination of B[a]P in STPs, cigarette filler and tobacco. Tobacco is extracted using methanol followed by solid-phase extraction and concentration prior to analysis by gas chromatography/mass spectrometry in the selected ion monitoring mode. Cooperation Centre for Scientific Research Relative to Tobacco reference products and 3R4F Kentucky reference cigarette filler were used for method validation. All method validation requirements were met including linearity, accuracy, precision, robustness, limit of detection (LOD) and limit of quantitation (LOQ), and stability. Calibration range of 0.5-125 ng mL-1 was achieved with the coefficient of determination (R2) greater than 0.995. The method LOQ and LOD were 0.729 and 0.216 ng/g, respectively. Using standardized methods for the measurement of HPHCs in tobacco products will reduce variability and ensure accurate data for regulatory reporting.

Evidence supporting product standards for carcinogens in smokeless tobacco products.

Smokeless tobacco products sold in the United States vary significantly in yields of nicotine and tobacco-specific nitrosamines (TSNA). With the passage of the Family Smoking Prevention and Tobacco Control Act, the Food and Drug Administration now has the authority to establish product standards. However, limited data exist determining the relative roles of pattern of smokeless tobacco use versus constituent levels in the smokeless tobacco product in exposure of users to carcinogens. In this study, smokeless tobacco users of brands varying in nicotine and TSNA content were recruited from three different regions in the U.S. Participants underwent two assessment sessions. During these sessions, demographic and smokeless tobacco use history information along with urine samples to assess biomarkers of exposure and effect were collected. During the time between data collection, smokeless tobacco users recorded the amount and duration of smokeless tobacco use on a daily basis using their diary cards. Results showed that independent of pattern of smokeless tobacco use and nicotine yields, levels of TSNA in smokeless tobacco products played a significant role in carcinogen exposure levels. Product standards for reducing levels of TSNA in smokeless tobacco products are necessary to decrease exposure to these toxicants and potentially to reduce risk for cancer.

Smokeless tobacco marketing and sales practices in Appalachian Ohio following federal regulations.

INTRODUCTION: Smokeless tobacco (ST) use is increasingly prevalent among poor and vulnerable groups, especially rural males. Access to tobacco products, as well as marketing messages, is associated with tobacco usage. In June 2010, the Tobacco Control Act (TCA) marked the beginning of federal regulation of the sale and marketing of tobacco products--including ST. The goal of this study was to describe marketing practices over time and to provide early assessment of the federal regulation in rural tobacco-licensed retail outlets. METHODS: Observational data were collected from a sample of retail outlets within three Ohio Appalachian counties. From an estimated 300 retail establishments, a stratified random sample was drawn (n = 86). Trained observers surveyed the sales and marketing of tobacco products. Baseline surveys were conducted between November 2009 and May 2010 before the TCA; follow-up surveys were repeated in August 2010. RESULTS: Follow-up surveys were completed for 79 tobacco-licensed retail outlets. The majority of retail outlets were gas stations or convenience stores. Compared with baseline, there was a significant reduction in the frequency of exterior and interior advertisements observed after the TCA (p < .01). Despite the lack of change in the proportion of stores advertising ST, the number of ST brands being advertised doubled between baseline and follow-up. CONCLUSION: Initial compliance with certain elements of the federal restrictions appears to be high in Appalachian Ohio. The significant increase in ST brands advertised suggests that advertising remains a clear presence in retail outlets in Appalachian Ohio.

Chemical and toxicological characterization of commercial smokeless tobacco products available on the Canadian market.

Some health experts are recommending that smokers who refuse to quit or refuse to use nicotine replacement therapy (NRT) such as nicotine-containing chewing gum switch to certain types of smokeless tobacco products (STP) such as Swedish snus. Other health experts disagree citing the uncertainty in the composition of commercially available STP, the lack of governmental regulations to ensure that STP advertised to meet certain standards (i.e., GothiaTek) do actually meet such standards, and the uncertainty that any STP can provide as safe as alternative to smoking as NRT. One reason for uncertainty is the dearth of detailed chemical and toxicological information on contemporary STP. Unlike the situation with cigarettes, there are few standardized methods for analytical and toxicological studies of STP. Consequently, the objective for this work was to characterize several types of STP available on the Canadian market using the modifications of the Official Health Canada chemical and toxicological methods developed for cigarettes. Moist snuff samples tested had TSNA and B[a]P levels somewhat above the GothiaTek standard while samples of Swedish snus, low-moisture snuff, and US-style chewing tobacco did not. Use of in vitro assays to assess STP toxicity was of limited utility in distinguishing product types.

Tobacco control policies and the concurrent use of smokeless tobacco and cigarettes among men, 1992-2002.

Accelerating the decline in smoking prevalence requires an understanding of changes in the concurrent use of and the substitution between different tobacco products, such as smokeless tobacco (SLT) and cigarettes. SLT could play an important role in reducing the toll of smoking-related illness and premature mortality. Research examining the role of tobacco control policies in explaining concurrent use of SLT and cigarettes has been minimal. Using the Current Population Survey Tobacco Use Supplements (CPS-TUS), we examined tobacco control policies in relationship with adult males' SLT use concurrent with smoking over the period 1992-2002. Consistent with the decline in smokeless-only and cigarette-only rates, concurrent use of SLT and cigarettes declined during the period. SLT users, faced with home or workplace smoking bans, are less likely to report smoking. Smokers with a home ban appear more likely to use SLT, but in more recent years, smokers with a workplace ban are less likely to use SLT. Tobacco excise taxes do not signal substitution between cigarettes and SLT products. Understanding current use patterns of the range of tobacco products, including their interaction with available policy levers, is vital in assessing whether changes that might promote substitution of arguably less toxic SLT products for highly toxic cigarettes are likely to lead to net public health gains or losses. Findings of the present study, in concert with other research about transitional probabilities between behavioral states, will inform the design of an effective policy framework that supports the objective of reducing tobacco-related death and disease.

Declaración de las asociaciones de profesionales de la salud municipios de Santa Cruz, Trinidad, Cobija y Cochabamba / Es

Declaración de las asociaciones de profesionales de la salud de las Américas sobre el control del tabaco. Reconociendo que el consumo del tabaco y la exposición pasiva al humo de tabaco mata al menos a un millón de personas anualmente en la región y por tanto es una de las principales causas evitables de muerte en las Américas

Notice regarding requirement for annual submission of the quantity of nicotine contained in smokeless tobacco products manufactured, imported, or packaged in the United States. Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. Notice.

This notice establishes a uniform protocol for the analysis of nicotine, total moisture, and pH in smokeless tobacco products. This protocol was designed to implement the requirement of the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) of 1986 (15 U.S.C. 4401 et seq., Pub. L. 99-252), which requires that each entity manufacturing, packaging, or importing smokeless tobacco products shall annually provide the Secretary of Health and Human Services (HHS) with a specification of the quantity of nicotine contained in each smokeless tobacco product.