Assessing consumer use and behaviour patterns of oral nicotine pouches in a multi-country study

Prasad, Krishna; Shetty, Mandara; Kanitscheider, Claudia; Szentes, Boglárka; Nassar, Rokaya; Edward, Lauren

doi:10.18203/issn.2454-2156.intjscirep20221344

Cited by 6 publications

(5 citation statements)

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“…For mRNA extraction, 5 × 10 5 cells were seeded into each well of 6-well plates and allowed to attach for 24 h. Cells were then exposed to diluted 20-min sample extracts for 4 h. The 20 min sample extracts were chosen as it is a common product use duration according to a survey by one product manufacturer (Prasad et al 2022 ). A 4 h exposure was used for gene expression experiments as it has been reported that gene expression of IL8 and IL6 have their peak after 4 to 8 h. Subsequently, mRNA was isolated using the NucleoSpin RNA, Mini kit for RNA purification (Macherey Nagel, Düren, Germany).…”

Section: Methodsmentioning

confidence: 99%

Oral nicotine pouches with an aftertaste? Part 2: in vitro toxicity in human gingival fibroblasts

Rinaldi¹,

Pieper²,

Schulz³

et al. 2023

Arch Toxicol

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Nicotine pouches contain fewer characteristic toxicants than conventional tobacco products. However, the associated risks in terms of toxicity and addiction potential are still unclear. Therefore, endpoints of toxicity and contents of flavoring substances were investigated in this study. The in vitro toxicity of five different nicotine pouches and the reference snus CRP1.1 were studied in human gingival fibroblasts (HGF-1). Cells were exposed to product extracts (nicotine contents: 0.03–1.34 mg/mL) and sampled at different time points. Cytotoxicity, total cellular reactive oxygen species (ROS) levels, and changes in the expression levels of inflammatory and oxidative stress genes were assessed. Flavor compounds used in the nicotine pouches were identified by GC–MS. Cytotoxicity was observed in two nicotine pouches. Gene expression of interleukin 6 (IL6) and heme oxygenase 1 (HMOX1) was upregulated by one and three pouches, respectively. ROS production was either increased or decreased, by one pouch each. CRP1.1 caused an upregulation of IL6 and elevated ROS production. Toxicity was not directly dependent on nicotine concentration and osmolarity. A total of 56 flavorings were detected in the five nicotine pouches. Seven flavorings were classified according to the harmonized hazard classification system as laid down in the European Classification, Labelling and Packaging regulation. Nine flavorings are known cytotoxins. Cytotoxicity, inflammation, and oxidative stress responses indicate that adverse effects such as local lesions in the buccal mucosa may occur after chronic product use. In conclusion, flavorings used in nicotine pouches likely contribute to the toxicity of nicotine pouches.

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Section: Methodsmentioning

confidence: 99%

Oral nicotine pouches with an aftertaste? Part 2: in vitro toxicity in human gingival fibroblasts

Rinaldi¹,

Pieper²,

Schulz³

et al. 2023

Arch Toxicol

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“…In three studies, the participants kept the products for 60 min in their oral cavities ( Lunell et al, 2020 ; Azzopardi et al, 2022b ; McEwan et al, 2022 ), which is three times the use duration compared with the presented study. A use duration of 20 min was chosen for two reasons: Firstly, a market survey conducted by a product manufacturer has revealed that the preferred duration for holding nicotine pouches in the oral cavity ranges from 5 to 20 min in Germany ( Prasad et al, 2022 ). The higher the nicotine strength of the pouch, the shorter was the preferred hold time ( Prasad et al, 2022 ).…”

Section: Discussionmentioning

confidence: 99%

“…A use duration of 20 min was chosen for two reasons: Firstly, a market survey conducted by a product manufacturer has revealed that the preferred duration for holding nicotine pouches in the oral cavity ranges from 5 to 20 min in Germany ( Prasad et al, 2022 ). The higher the nicotine strength of the pouch, the shorter was the preferred hold time ( Prasad et al, 2022 ). Secondly, as no clinical data for the use of pouches with high nicotine concentrations were available, it was unclear how participants would react to such a high nicotine dose.…”

Section: Discussionmentioning

confidence: 99%

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Small pouches, but high nicotine doses—nicotine delivery and acute effects after use of tobacco-free nicotine pouches

Mallock-Ohnesorg,

Rabenstein,

Stoll

et al. 2024

Front. Pharmacol.

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Tobacco-free nicotine pouches are new nicotine products for oral consumption. They can contain very high nicotine amounts that have not been addressed with clinical studies yet. Thus, nicotine delivery, effects on craving, and side effects were assessed using pouches with up to 30 mg nicotine. In this single-center, five-arm, crossover study, 15 regular cigarette smokers consumed tobacco-free nicotine pouches from different brands with 6, 20, and 30 mg for 20 min. Comparators were nicotine-free pouches and tobacco cigarettes. At baseline and predefined time points over a study period of 240 min, plasma nicotine concentrations, effects on cigarette craving, and side effects were assessed. Cardiovascular parameters including arterial stiffness were measured using a MobilOGraph. Consumption of 30 mg nicotine pouches has led to a higher nicotine uptake compared with the cigarette (Cmax: 29.4 vs 15.2 ng/mL; AUC: 45.7 vs 22.1 ng/mL × h). Nicotine uptake in the acute phase was rapid during use of the 30 mg pouch and cigarette. Extraction rate of nicotine differed between pouches. Use of all products has reduced acute cigarette craving, even the nicotine-free pouch. During consumption of the cigarette and the pouches with 20 and 30 mg, heart rate increased about 27, 12, and 25 bpm, respectively. Parameters for arterial stiffness were elevated and all pouches have induced mouth irritations. The pouches with 30 mg nicotine had overall the strongest side effects and may induce addiction. As craving was also reduced by products with less nicotine, it is questionable whether such high nicotine contents should be allowed on the market. A limit of nicotine content is warranted. The nicotine release rate varies across products and needs to be known to estimate the nicotine delivery.

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“…For the “worst-case scenario”, it was assumed that a person of 70 kg weight consumes 20 pouches per day. Both assumptions are based on previously published surveys (Havermans et al 2021 ; Prasad et al 2022 ). Since consumers are exposed to additives via serval exposure routes (e.g., food, cosmetics, and nicotine pouches), it was decided to calculate with 50% of the respective ADI value.…”

Section: Methodsmentioning

confidence: 99%

Oral nicotine pouches with an aftertaste? Part 1: screening and initial toxicological assessment of flavorings and other ingredients

et al. 2023

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Nicotine pouches are oral products that deliver nicotine without containing tobacco. Previous studies mainly focused on the determination of known tobacco toxicants, while yet no untargeted analysis has been published on unknown constituents, possibly contributing to toxicity. Furthermore, additives might enhance product attractiveness. We therefore performed an aroma screening with 48 different nicotine-containing and two nicotine-free pouches using gas chromatography coupled to mass spectrometry, following acidic and basic liquid–liquid extraction. For toxicological assessment of identified substances, European and international classifications for chemical and food safety were consulted. Further, ingredients listed on product packages were counted and grouped by function. Most abundant ingredients comprised sweeteners, aroma substances, humectants, fillers, and acidity regulators. 186 substances were identified. For some substances, acceptable daily intake limits set by European Food Safety Agency (EFSA) and Joint FAO/WHO Expert Committee on Food Additives are likely exceeded by moderate pouch consumption. Eight hazardous substances are classified according to the European CLP regulation. Thirteen substances were not authorized as food flavorings by EFSA, among them impurities such as myosmine and ledol. Three substances were classified by International Agency for Research on Cancer as possibly carcinogenic to humans. The two nicotine-free pouches contain pharmacologically active ingredients such as ashwagandha extract and caffeine. The presence of potentially harmful substances may point to the need for regulation of additives in nicotine-containing and nicotine-free pouches that could be based on provisions for food additives. For sure, additives may not pretend positive health effects in case the product is used.

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Assessing consumer use and behaviour patterns of oral nicotine pouches in a multi-country study

Cited by 6 publications

References 0 publications

Oral nicotine pouches with an aftertaste? Part 2: in vitro toxicity in human gingival fibroblasts

Oral nicotine pouches with an aftertaste? Part 2: in vitro toxicity in human gingival fibroblasts

Small pouches, but high nicotine doses—nicotine delivery and acute effects after use of tobacco-free nicotine pouches

Oral nicotine pouches with an aftertaste? Part 1: screening and initial toxicological assessment of flavorings and other ingredients

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