A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic, pharmacodynamic and safety and tolerability profiles of tobacco-free oral nicotine pouches relative to cigarettes

Chapman, Fiona; McDermott, Simon; Rudd, Kathryn; Taverner, Victoria; Stevenson, Matthew; Chaudhary, Nveed; Reichmann, Kerstin; Thompson, Joseph; Nahde, Thomas; O’Connell, Grant

doi:10.1007/s00213-022-06178-6

Cited by 11 publications

(24 citation statements)

References 32 publications

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“…Te study confrms pharmacokinetics profle of ONPs is mainly oral mucosal absorption and not via swallowing/G.I. absorption [7]. Te time of maximum nicotine concentration observed (T max ) for the pouches products ranges from 22-26 minutes to 60 minutes [7,22].…”

Section: Onps Usage and Nicotine Absorptionmentioning

confidence: 94%

“…ONPs are composed of a permeable pouch and a nontobacco substrate to which nicotine and favors are added [6,7]. Te outer pouch material comprises viscose fbers bound together by chemical, heat, or solvent treatment.…”

Section: Major Constituents and Categories Of Onpsmentioning

confidence: 99%

“…ONPs are preportioned pouches similar to Snus, with a diference from Snus in that there is no leaf tobacco in them [7]. Tey can be used almost anywhere since they are a convenient, tasty, and discreet way to use nicotine.…”

Section: Introductionmentioning

confidence: 99%

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Emerging Oral Nicotine Products and Periodontal Diseases

Rahman

2023

International Journal of Dentistry

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Oral nicotine pouches are emerging as a new “modern oral” nicotine product. These prefilled pouches contain nicotine, flavorings, and filling agents that dissolve in the mouth. Nicotine can be derived from tobacco leaf or chemical synthesis. Traces of TSNAs and toxic chromium were detected in the pouch products. This raises the concern about general and periodontal health. This review aims to update the current oral nicotine products research relating to periodontal disease and its relevance in periodontal inflammation. Nicotine interacts with host cells and affects inflammatory responses to microbial challenges. It may directly or indirectly deteriorate periodontal tissues by activating nicotinic acetylcholine receptors, repressing PDL fibroblasts cells, increasing cellular ROS and cytokines/chemokines, growth factors, breaking microbiota balance, and dysregulating miRNAs expression. Studies show that appealing flavorings contained in nicotine pouches pose harm to periodontal innate immune responses and increase penetration of nitrosamines. In addition, flavored ONPs increase the risk of dual or poly-tobacco products among young adults, stacking up detrimental effects on the periodontium. Given the recent growth of users, further studies are needed to elucidate the impact of ONPs, even poly-tobacco use, on systemic and periodontal health. Moreover, policymakers should ensure to avoid generating a new wave of nicotine addiction among youths in the U.S.

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Section: Onps Usage and Nicotine Absorptionmentioning

confidence: 94%

Section: Major Constituents and Categories Of Onpsmentioning

confidence: 99%

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Emerging Oral Nicotine Products and Periodontal Diseases

Rahman

2023

International Journal of Dentistry

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“…Concerning the additional approaches of the ONPs, studies also report the impact of ONPs on lung as case studies put forward that pulmonary aspirations of smokeless tobacco products activate recurrent pulmonary infiltrations and multifocal airway obstructions in the lungs of the users probably causing aspiration pneumonia [44]. Recent evidence investigated the pharmacokinetic parameters of ONPs and reported that oral nicotine pouches carry the potential to be an acceptable substitute for adult smokers as the users can achieve adequate nicotine levels to deliver into the body [45]. Our recent in vitro investigation focused on oral-pulmonary health effects of Snus and ONPs indicating that the flavored ONPs are risky and likely to cause local and systematic toxicological responses during chronic consumption [27].…”

Section: Application Of Onps In Research Studiesmentioning

confidence: 99%

Classification, Perception, Sociological Aspects, and Toxicity of Emerging Flavored Oral Nicotine Pouches

Shaikh¹,

Newton²,

Tung³

et al. 2023

Preprint

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Introduction: Oral Nicotine Pouches (ONPs) are the new form of nicotine pouches that have become a type of emerging smokeless tobacco product sold by various tobacco companies. These smokeless tobacco products are being marketed for usage all over as Snus containing tobacco-derived nicotine (Natural) or as tobacco-free nicotine (Synthetic) as substitutes for other tobacco products that are limited in public places. ONPs have become popular tobacco products among adolescents/young adults and over 50% of young adult users of ONP use flavored ONP, such as menthol/mint, tobacco, dessert/candy, and fruity, being the most popular flavors. Various new ONP flavors are currently popular locally as well in the online market. Tobacco, Menthol, and fruit-flavored ONPs could motivate cigarette smokers to alteration to ONPs. Methods: We expanded our knowledge on natural/synthetic ONP flavors wheels to available data on ONPs, describing in detail their flavors and brands (US and Europe) in both natural/Synthetic ONP categories. We classified over 152 snus and 228 synthetic ONPs into the following flavor categories: “Tobacco”, “Menthol/Mint”, “Fruity”, “Candy/Deserts”, “Drink”, “Aroma”, “Spices” and “Mixed Flavors”. Results: Based on total numbers, wefound that the most popular ONPs flavor sold as tobacco and menthol to be among natural ONPs, among synthetic ONPs fruity and menthol as the most prominent flavors with varying concentrations of nicotine and other flavoring chemicals including coolant WS-23. We also illustrated possible molecular targets and toxicities due to exposure to ONPs activating several signaling cascades like AKT and NF-B might possibly lead to apoptosis and epithelial mesenchymal transition (EMT). Conclusions: Considering the marketing of ONP products with various flavor profiles and most of these products containing tobacco/menthol/fruit flavor, it is likely to have regulation and marketing disclaimer on some of these products. Further, it would be logical to determine how the market reacts in terms of compliance and non-compliance with flavor restrictions by the regulatory agencies.

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“…Despite the significant increases in the usage of ONPs in the U.S., limited studies have been conducted so far that have delved into understanding the health effects of ONP usage [4,[12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Flavor Classification/Categorization and Differential Toxicity of Oral Nicotine Pouches (ONPs) in Lung Epithelial Cells

Shaikh

Tung

Lucas

et al. 2022

Preprint

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The prevalence of flavored tobacco product usage amongst youth in the United States is partly due to the emergence of non-combustible nicotine-containing products (NCNPs), including oral nicotine pouches (ONPs) and smokeless tobacco products. ONPs are available in various different flavors (mint, fruity, tobacco, dessert, citrus, coffee, wintergreen, and berry) and may use either Tobacco-Derived Nicotine (TDN) or Tobacco-Free Nicotine (TFN). Currently, several brands of ONPs are sold in the U.S and comprise a significant portion of NCNP sales in the U.S. There is a growing concern that flavored ONPs may not only induce oral health effects, but may also induce systemic toxic effects due to nicotine and other ONP byproducts being absorbed into systemic circulation through the oral mucosa. These byproducts can act locally on other tissues and may potentially cause redox dysregulation and heightened inflammatory responses systemically in the respiratory, cardiovascular, and/or renal systems. Hence, we determined the effects of flavored ONPs from four of the most widely sold brands in the U.S in inducing toxicological effects on the respiratory epithelium. Prior to analyzing the effects ONPs, we first classified ONPs sold in the US based on their flavor and the flavor category to which they belong to using a wheel diagram. Subsequently, using human bronchial epithelial cells (16-HBE and BEAS-2B) exposed to extracts of flavored ONPs, we assessed the levels of ONP-induced inflammatory cytokine release (IL-6 and IL-8), cellular Reactive Oxygen Species (ROS) production, and cytotoxicity in the airway epithelium. Our data showed that cells exposed to the lowest concentration treatments showed increased cytotoxicity, differential cellular ROS production, and proinflammatory cytokine release. The most striking response was observed among cells treated with the spearmint ONP, whereas ONPs containing original tobacco and fruity flavors showed varied levels of ROS release in 16-HBE cells. Our data suggest that flavored ONPs are unsafe and likely to cause systemic and local toxicological responses during chronic usage. Our study is a part of ongoing efforts to use in vitro, ex-vivo, and in vivo systems to understand how the usage of various flavored ONPs may cause both oral and pulmonary toxicity, and impact human periodontal health.

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A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic, pharmacodynamic and safety and tolerability profiles of tobacco-free oral nicotine pouches relative to cigarettes

Cited by 11 publications

References 32 publications

Emerging Oral Nicotine Products and Periodontal Diseases

Emerging Oral Nicotine Products and Periodontal Diseases

Classification, Perception, Sociological Aspects, and Toxicity of Emerging Flavored Oral Nicotine Pouches

Flavor Classification/Categorization and Differential Toxicity of Oral Nicotine Pouches (ONPs) in Lung Epithelial Cells

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